Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808022

FEI Number

3002808022

Entity Name

ROSE GMBH FUER MEDIZINTECHNIK

City/State/Country

Trier Rhineland-Palatinate, DE

Establishment Address

Gottbillstrasse 25, Trier Rhineland-Palatinate 54294, DE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Rose GmbH fuer Medizintechnik (Owner Number: 10042910)

Owner / Operator Contact Address

Gottbillstrasse 25, Trier, DE-RP 54294, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CERAMENT Bone Void Filler XAGA Surgical Unit GII-CR PE-INSERT GII-PS INSERT GII-CC PE-INSTERT GII DISHED INSERT COPAL exchange G hip Spacer, COPAL G+V GII-PS HIGH FLEXION INSERT RAUMEDIC-ICP-Monitoring-System Vitreq Forceps D253555 REF: FC27.D07 Vitreq Forceps D253555 REF: FC25.D04 Vitreq Forceps D253555 REF: FC23.D02 Vitreq Forceps D253555 REF: FC23.D03 Vitreq Forceps D253555 REF: FC25.D05 Vitreq Forceps D253555 REF: FC27.D05 Vitreq Forceps D253555 REF: FC25.D02 Vitreq Forceps D253555 REF: FC25.D03 Vitreq Forceps D253555 REF: FC23.D07 Vitreq Forceps D253555 REF: FC27.D03 Vitreq Forceps D253555 REF: FC23.D04 Vitreq Forceps D253555 REF: FC23.D06 Vitreq Forceps D253555 REF: FC25.D06 Vitreq Forceps D253555 REF: FC25.D07 Vitreq Forceps D253555 REF: FC23.D05 GII-CC PE-INSERT HYBRIDknife® flex REF: 20150-113 HYBRIDknife® flex REF: 20150-112 HYBRIDknife® flex REF: 20150-111 HYBRIDknife® flex REF: 20150-110 NEVISENSE Vitreq Cannula D253552 REF: BF00.D53 Vitreq Cannula D253552 REF: BF25.D01 Vitreq Cannula D253552 REF: BF25.D07 Vitreq Cannula D253552 REF: SQ00.D01 Vitreq Cannula D253552 REF: CN23.D01 Vitreq Cannula D253552 REF: CN23.D03 Vitreq Cannula D253552 REF: SQ00.D02 Vitreq Cannula D253552 REF: BF23.D05 Vitreq Cannula D253552 REF: BF00.D51 Vitreq Cannula D253552 REF: BF25.D05 Vitreq Cannula D253552 REF: BF23.D01 Vitreq Cannula D253552 REF: BF27.D02 Vitreq Cannula D253552 REF: CN25.D03 Vitreq Cannula D253552 REF: BF23.D02 Vitreq Cannula D253552 REF: BF27.D01 Vitreq Cannula D253552 REF: BF23.D07 Vitreq Cannula D253552 REF: BF25.D02 Vitreq Cannula D253552 REF: BF00.D52 Vitreq Cannula D253552 REF: CN25.D01 Vitreq Cannula D253552 REF: CN27.D03 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-745/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-744/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-786/36 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-772/32 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-785/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-741/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-761/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-745/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-786/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-785/36 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-753/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-754/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-753/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-355/28 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-756/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-756/36 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-785/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-782/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-765/32 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-781/28 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-755/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-784/36 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-752/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-745/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-353/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-356/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-761/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-763/36 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-751/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-763/32 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-772/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-773/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-760/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-764/36 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-773/36 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-752/28 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-755/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-762/32 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-783/32 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-783/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-743/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-742/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-356/32 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-772/36 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-356/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-775/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-762/36 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-775/32 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-782/36 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-784/28 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-756/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-746/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-744/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-750/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-784/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-740/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-783/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-774/32 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-771/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-752/32 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-781/32 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-776/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-765/36 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-351/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-773/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-751/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-755/36 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-776/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-355/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-766/28 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-786/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-762/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-746/32 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-754/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-746/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-743/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-352/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-742/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-352/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-763/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-776/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-353/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-743/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-354/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-355/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-350/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-354/36 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-771/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-741/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-764/32 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-774/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-766/32 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-766/36 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-782/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-742/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation 183-744/36 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-354/28 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-754/36 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-351/32 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-352/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-775/28 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-774/36 MobileLink UHMWPE Inserts -X-LINKed; 20° inclination, + 8 / 12 mm offset 183-780/28 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-764/28 MobileLink UHMWPE Inserts -X-LINKed; + 4 mm offset 183-753/36 MobileLink UHMWPE Inserts -X-LINKed; Anti-luxation + 4 mm offset 183-765/28 MobileLink UHMWPE Inserts -X-LINKed; Standard (Neutral) 183-353/32 MobileLink UHMWPE Inserts -X-LINKed; 10° inclination, + 4 mm Offset 183-770/28 Vitreq Scissors D253556 REF: SC25.D01 Vitreq Scissors D253556 REF: SC25.D03 Vitreq Scissors D253556 REF: SC27.D01 Vitreq Scissors D253556 REF: SC25.D02 Vitreq Scissors D253556 REF: SC23.D02 Vitreq Scissors D253556 REF: SC23.D03 Vitreq Scissors D253556 REF: SC23.D01 Vitreq Scissors D253556 REF: SC27.D03 MAJ-1607/1608 Volumat Lines ulrichINJECT CT motion COMBI 40+ Cochlear Implant System: Maestro Cochlear Implant System Magnet Replacement Kit (Replacement Magnet & Non-Magnetic Spacer) Mi1000 MED-EL CONCERT Cochlear Implant PULSAR CI 100 Vibrant Soundbridge (VORP 502) Mi1250 SYNCHRONY 2 PIN Cochlear Implant Mi1250 SYNCHRONY 2 Cochlear Implant Mi1200 SYNCHRONY PIN Cochlear Implant SONATA TI N100 Cochlear Implant Mi1210 SYNCHRONY ST Cochlear Implant Mi1000 MED-EL CONCERT PIN Cochlear Implant Insertion Electrode (IE) Variants Insertion Test Device (ITD) Mi1200 SYNCHRONY Cochlear Implant Mi1250 SYNCHRONY 2 PIN Cochlear Implant with S- Vector Magnet S- Vector Magnet Replacement Kit (S- Vector Replacement Magnet & Non- Magnetic Spacer) Mi1260 SONATA 2 Cochlear Implant Mi1250 SYNCHRONY 2 Cochlear Implant with S- Vector Magnet MOVIVA® Hybrid Ablation Probe REF: 20150-120 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H11 Symmetric Sz. 3-4 880-293/11 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H12 Symmetric Sz. 5-6 880-295/12 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H14 Symmetric Sz. 5-6 880-295/14 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H11 Symmetric Sz. 7-8 880-297/11 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H18 Symmetric Sz. 3-4 880-293/18 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H18 Symmetric Sz. 5-6 880-295/18 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H18 Symmetric Sz. 7-8 880-297/18 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H10 Symmetric Sz. 5-6 880-295/10 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H16 Symmetric Sz. 3-4 880-293/16 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H12 Symmetric Sz. 1-2 880-291/12 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H16 Symmetric Sz. 9-10 880-299/16 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H11 Symmetric Sz. 9-10 880-299/11 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H10 Symmetric Sz. 1-2 880-291/10 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H11 Symmetric Sz. 1-2 880-291/11 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H12 Symmetric Sz. 7-8 880-297/12 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H14 Symmetric Sz. 3-4 880-293/14 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H14 Symmetric Sz. 1-2 880-291/14 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H18 Symmetric Sz. 9-10 880-299/18 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H12 Symmetric Sz. 3-4 880-293/12 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H16 Symmetric Sz. 7-8c 880-297/16 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H14 Symmetric Sz. 7-8 880-297/14 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H16 Symmetric Sz. 5-6 880-295/16 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H12 Symmetric Sz. 9-10 880-299/12 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H10 Symmetric Sz. 3-4 880-293/10 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H16 Symmetric Sz. 1-2 880-291/16 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H14 Symmetric Sz. 9-10 880-299/14 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H11 Symmetric Sz. 5-6 880-295/11 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H10 Symmetric Sz. 7-8 880-297/10 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H10 Symmetric Sz. 9-10 880-299/10 LinkSymphoKnee Articulating Surface, UC, fixed bearing, E-DUR, H18 Symmetric Sz. 1-2 880-291/18 LEGION PS HIGH FLEX.XLPE-EINS. REF.ALL-POLY.CUP ERBEJET® 2 System REF: 20150-231 ERBEJET® 2 System REF: 20150-225 ERBEJET® 2 System REF: 20150-238 ERBEJET® 2 System REF: 20150-239 ERBEJET® 2 System REF: 20150-230 ERBEJET® 2 System REF: 20150-220 ERBEJET® 2 System REF: 20150-226 ulricheasyINJECT Max Vitreq Retractable Tissue Manipulator D273591 REF: TM23.D01 Vitreq Retractable Tissue Manipulator D273591 REF: TM25.D01 Uni FB PE-insert ID = 40100208 Uni FB PE-insert ID = 40100309 Uni FB PE-insert ID = 40100108 Uni FB PE-insert ID = 40101010 Uni FB PE-insert ID = 40100212 Uni FB PE-insert ID = 40100310 Uni FB PE-insert ID = 40100411 Uni FB PE-insert = 40100412 Uni FB PE-insert ID = 40100409 Uni FB PE-insert ID = 40100210 Uni FB PE-insert ID = 40101014 Uni FB PE-insert ID = 40101012 Uni FB PE-insert ID = 40100414 Uni FB PE-insert ID = 40100311 Uni FB PE-insert ID = 40100214 Uni FB PE-insert ID = 40100111 Uni FB PE-insert ID = 40100312 Uni FB PE-insert ID = 40100410 Uni FB PE-insert ID = 40100209 Uni FB PE-insert ID = 40100109 Uni FB PE-insert ID = 40101011 Uni FB PE-insert ID = 40101009 Uni FB PE-insert ID = 40100110 Uni FB PE-insert ID = 40100114 Uni FB PE-insert ID = 40100308 Uni FB PE-insert ID = 40100314 Uni FB PE-insert ID = 40100211 Uni FB PE-insert ID = 40100112 Uni FB PE-insert ID = 40101008 Uni FB PE-insert ID = 40100408 implacross® E PE insert 15 4mm offset ID = 02483644 implacross® E PE insert 15 ID = 02373652 implacross® E PE insert 15 ID = 02373244 implacross® E PE insert 0 4mm offset ID = 02353248 implacross® E PE insert 15 4mm offset ID = 02483648 implacross® E PE insert 15 4mm offset ID = 02483652 implacross® E PE insert 10 4mm offset ID = 02363652 implacross® E PE insert 0 4mm offset ID = 02353244 implacross® E PE insert 0 4mm offset ID = 02353644 implacross® E PE insert 15 ID = 02373252 implacross® E PE insert 0 4mm offset ID = 02353648 implacross® E PE insert 15 4mm offset ID = 02483239 implacross® E PE insert 15 ID = 02373248 implacross® E PE insert 10 4mm offset ID = 02363648 implacross® E PE insert 10 4mm offset ID = 02363252 implacross® E PE insert 10 4mm offset ID = 02363248 implacross® E PE insert 15 4mm offset ID = 02483244 implacross® E PE insert 15 4mm offset ID = 02483248 implacross® E PE insert 15 ID = 02373648 implacross® E PE insert 15 4mm offset ID = 02483252 implacross® E PE insert 0 4mm offset ID = 02353252 implacross® E PE insert 15 ID = 02373644 implacross® E PE insert 10 4mm offset ID = 02363644 implacross® E PE insert 0 4mm offset ID = 02353239 implacross® E PE insert 10 4mm offset ID = 02363244 implacross® E PE insert 0 4mm offset ID = 02353652 implacross® E PE insert 15 ID = 02373239 implacross® E PE insert 10 4mm offset ID = 02363239 Vitreq Needle D253554 REF: BF23.D52 Vitreq Needle D253554 REF: CN25.D04 Vitreq Needle D253554 REF: MD25.D01 Vitreq Needle D253554 REF: BF25.D51 Vitreq Needle D253554 REF: BF23.D51 Vitreq Needle D253554 REF: CN23.D05 Vitreq Needle D253554 REF: MD23.D01 Vitreq Needle D253554 REF: CN27.D05 Vitreq Needle D253554 REF: CN23.D04 Vitreq Needle D253554 REF: CN25.D05 Vitreq Needle D253554 REF: BF25.D52 Straumann Jason membrane Jason membrane FiAPC plus probes REF: 20132-324 FiAPC plus probes REF: 20132-323 FiAPC plus probes REF: 20132-321 HybridAPC probe REF: 20150-215 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-262/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-254/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/24 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-241/10 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-264/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/16 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-245/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-252/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-254/14 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/14 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-249/11 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-257/18 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-261/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/24 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/20 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/14 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/10 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-245/11 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-257/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-263/10 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-241/12 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-267/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-255/16 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/10 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-267/16 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-243/10 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-267/11 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-263/18 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-261/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-259/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-251/14 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/22 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-269/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/10 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-249/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-259/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-254/18 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-255/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-253/16 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-265/14 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-245/16 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-267/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/22 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/20 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-264/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/24 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-257/16 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-247/16 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/16 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/24 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/12 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-241/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-254/16 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-261/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-254/12 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-264/16 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-243/14 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/20 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-251/10 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-247/11 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-252/16 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-269/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/22 LinkSymphoKnee Patella Component, E-DUR / 880-511/34 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/24 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-247/14 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-243/16 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/22 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-262/12 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-261/18 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-259/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-255/10 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-269/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-262/18 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-249/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-257/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-251/18 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-265/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-255/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-264/11 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-252/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-252/12 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-245/18 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-253/12 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-269/11 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/18 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-247/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-252/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/16 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/22 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/16 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-262/16 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/20 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-267/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/20 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-245/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/18 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-241/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/24 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-265/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-254/11 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-263/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/14 LinkSymphoKnee Patella Component, E-DUR / 880-511/37 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/24 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-253/11 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-255/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/20 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-267/14 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-243/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/18 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-252/11 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-257/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-251/12 LinkSymphoKnee Patella Component, E-DUR / 880-511/31 LinkSymphoKnee Patella Component, E-DUR / 880-511/25 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-271/22 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-265/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-253/18 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-269/10 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-263/11 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-249/18 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-249/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-257/11 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-273/12 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-263/16 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-243/11 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-277/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-253/10 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-261/12 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-247/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/16 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-263/14 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/20 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/12 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-245/10 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-275/14 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-253/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-262/11 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-265/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/22 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-262/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-265/11 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-243/18 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-249/16 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-247/18 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-251/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-259/18 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/12 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-259/11 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-241/14 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-272/10 LinkSymphoKnee Patella Component, E-DUR / 880-511/28 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-264/10 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-255/11 LinkSymphoKnee Articulating Surface, CR, fixed bearing, E-DUR / 880-241/11 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-259/12 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-279/16 LinkSymphoKnee Articulating Surface, PS, fixed bearing, E-DUR / 880-251/11 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-264/14 LinkSymphoKnee Patella Component, E-DUR / 880-511/40 LinkSymphoKnee Articulating Surface, CCK, fixed bearing, E-DUR / 880-274/14 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-261/11 LinkSymphoKnee Articulating Surface, PS+, fixed bearing, E-DUR / 880-269/16 REFLECTION ALL-POLY.XLPE CUP Jason® membrane / Straumann® Jason® membrane RAUMEDIC-ICP-Temp-Monitoring-System Vitreq disposable laser probes, light fibers and Chandelier EM Disposable Stylet Goldtrace ulricheasyINJECT Max Reverse Inserts - cPE / 643-039/03 Reverse Inserts - inclined 10 - cPE / 643-039/10 Reverse Inserts - inclined 10 - E-Dur / 643-242/13 Reverse Inserts - inclined 10 - cPE / 643-042/16 Reverse Inserts - E-Dur / 643-239/00 Reverse Inserts - inclined 10 - E-Dur / 643-236/16 Reverse Inserts - inclined 20 - E-Dur / 643-239/23 Reverse Inserts - cPE / 643-042/03 Reverse Inserts - inclined 20 - E-Dur / 643-242/23 Reverse Inserts - cPE / 643-039/00 Reverse Inserts - inclined 20 - cPE / 643-039/23 Reverse Inserts - inclined 20 - E-Dur / 643-242/26 Reverse Inserts - cPE / 643-036/06 Reverse Inserts - inclined 10 - cPE / 643-039/13 Reverse Inserts - inclined 10 - E-Dur / 643-242/16 Reverse Inserts - E-Dur / 643-242/00 Reverse Inserts - E-Dur / 643-239/03 Reverse Inserts - inclined 20 - E-Dur / 643-239/26 Reverse Inserts - inclined 10 - E-Dur / 643-242/10 Reverse Inserts - cPE / 643-036/00 Reverse Inserts - inclined 20 - E-Dur / 643-242/20 Reverse Inserts - E-Dur / 643-239/06 Reverse Inserts - inclined 10 - E-Dur / 643-239/13 Reverse Inserts - inclined 20 - E-Dur / 643-236/26 Reverse Inserts - inclined 20 - E-Dur / 643-236/20 Reverse Inserts - inclined 10 - cPE / 643-036/13 Reverse Inserts - cPE / 643-042/00 Reverse Inserts - cPE / 643-042/06 Reverse Inserts - inclined 20 - cPE / 643-036/26 Reverse Inserts - inclined 20 - cPE / 643-036/23 Reverse Inserts - cPE / 643-036/03 Reverse Inserts - inclined 10 - cPE / 643-036/16 Reverse Inserts - E-Dur / 643-242/06 Reverse Inserts - cPE / 643-039/06 Reverse Inserts - inclined 10 - cPE / 643-042/13 Reverse Inserts - inclined 10 - E-Dur / 643-239/10 Reverse Inserts - inclined 20 - cPE / 643-036/20 Reverse Inserts - inclined 20 - cPE / 643-039/26 Reverse Inserts - inclined 10 - E-Dur / 643-236/13 Reverse Inserts - inclined 20 - cPE / 643-042/26 Reverse Inserts - inclined 10 - E-Dur / 643-236/10 Reverse Inserts - E-Dur / 643-236/06 Reverse Inserts - inclined 20 - cPE / 643-039/20 Reverse Inserts - inclined 20 - E-Dur / 643-236/23 Reverse Inserts - E-Dur / 643-236/03 Reverse Inserts - inclined 10 - cPE / 643-042/10 Reverse Inserts - inclined 20 - E-Dur / 643-239/20 Reverse Inserts - inclined 10 - cPE / 643-036/10 Reverse Inserts - inclined 20 - cPE / 643-042/20 Reverse Inserts - inclined 10 - E-Dur / 643-239/16 Reverse Inserts - inclined 10 - cPE / 643-039/16 Reverse Inserts - E-Dur / 643-242/03 Reverse Inserts - E-Dur / 643-236/00 Reverse Inserts - inclined 20 - cPE / 643-042/23 RAUMEDIC-ICP-Monitoring-System ventricular ulrichINJECT CT motion Magnet Replacement Kit (Replacement Magnet & Non-Magnetic Spacer) Insertion Electrode (IE) Variants Mi1000 MED-EL CONCERT PIN Cochlear Implant Insertion Test Device (ITD) Mi1000 MED-EL CONCERT Cochlear Implant SONATA TI 100 Cochlear Implant PULSAR CI 100 Mi1200 SYNCHRONY PIN Cochlear Implant Mi1200 SYNCHRONY Cochlear Implant Vibrant Soundbridge PE cup insert 10 ID = 2803148 PE cup insert 0 ID = 02803444 PE cup insert 0 ID = 2803439 PE cup insert 0 ID = 02803448 PE cup insert 10 ID = 02803152 PE cup insert 0 ID = 2803452 PE cup insert 10 ID = 02803139 PE cup insert 10 = 2803144 OrganOx Metra System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2016-11-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-06-02
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2014-07-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-10-31
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-09-02
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-05-29
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2024-05-29
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2024-05-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-10-31
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-10-31
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2014-06-09
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-02
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-10-31
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-04-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-27
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2014-09-11
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2014-09-11
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2014-09-11
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2014-09-11
ONV	Electrical Impedance Spectrometer	General, Plastic Surgery	Class 2	878.1820	2022-08-19
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2015-05-13
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-02
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2025-12-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-12-11
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-12-11
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-02
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2026-01-12
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2019-05-08
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2019-05-08
HQB	Photocoagulator And Accessories	Ophthalmic	Class 2	886.4690	2019-05-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-11-03
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2026-01-12
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-10-31
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2019-10-31
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-10-31
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2019-10-31
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2021-07-13
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2013-01-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-27
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-04-27
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2015-05-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-12-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-10-31
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-10-31
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-10-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-27
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-04-27
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2014-07-01
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2014-07-16
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-05-08
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2019-11-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2018-10-30
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2018-10-30
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2020-01-06
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2020-07-30
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-02-02
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2022-07-12
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-07-12
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2021-07-13
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-02-02
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2021-06-24
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2014-07-16
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2014-07-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-27
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2026-04-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-27
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2022-01-06
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2022-01-06
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2022-01-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-01-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-01-06
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2014-07-14
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2014-10-31
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2014-10-31
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2026-04-27
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2014-06-09
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2019-05-08
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2019-05-08
HQB	Photocoagulator And Accessories	Ophthalmic	Class 2	886.4690	2019-05-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-03-06
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2021-07-13
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2025-03-06
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2019-01-09
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-09-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-01-06
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-01-06
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-01-06
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2014-06-09
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2021-12-17
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2021-07-13
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2021-07-13
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2021-07-13
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2021-07-13
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown	Class 3	N/A	2013-01-10
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-10-27
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation	Unknown	Class 3	N/A	2026-01-12

Official Correspondent

Thomas Rose

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

Rose GmbH fuer Medizintechnik

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229

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3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808022. Last updated year: 2026. Please use registration number 3002808022 when referencing this establishment in official correspondence.