Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611112

FEI Number

3008782585

Entity Name

HEBUMEDICAL GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

BADSTRASSE 8, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HEBUMEDICAL GMBH (Owner Number: 8010320)

Owner / Operator Contact Address

BADSTRASSE 8, --, TUTTLINGEN, DE-NOTA 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knot Pusher Laparoscopic Accessories, Gynecologic Hudson Blade, Saw, General & Plastic Surgery Punch, Surgical Pin Distractor, threaded, 2,8mm Guide, Needle, Surgical Forceps, Dressing, Dental Robotic Integration Scalpel Holder 17-1092TC 18-1832A-TC 17-1090TC 17-1091TC Holder, Needle Instrument, ENT Manual Surgical Needle Holder Dressing Forceps Artery Forceps Haemostatic Forceps Various Models of Reusable Vein Strippers Stripper, Vein, Reusable Micro Camera Cable Micro Camera Nail Nipper Wire Holding Forceps Hook, Surgical, General & Plastic Surgery GAUGE 1352286 PISTON TRIMMING Special Skin Hook Chisel, Nasal HOUSE-HOUGH EXCAVATOR, 6-1/2, ANGLED 90DEGREES Light Source Adapter Light cable Packer, Uterine Hemostatic Forceps Hemostat Extractor Tenaculum, Uterine cable bipolar Chisel, Surgical, Manual Freer musous knife Converse rhinoplastic and nasal knife, 17,5cm, 6 3/4" Laryngeal mirror, cone socket, magnifying Elevator, Surgical, Dental Jansen & Other Scalp Retractor, Self-Retaining for Neurosurgery DeBakey Bulldog clamp Cooley hemostatic forceps DeBakey hemostatic forceps Cooley Bulldog clamp DeBakey Multi-Purpose-Clamp Cooley Multi-Purpose Clamp Cooley vein clamp DeBakey vein clamp DeBakey Vascular Clamp DELEE CERVICAL FORCEPS 9" Clamp, non-electrical POLLCK-DNGMN SEPTAL DISPL POLLOCK-DINGMAN DISPLACER 8 Scissors, General & Plastic Surgery Scaler, Periodontic BLADE 1352282 O/R TABLE BRACKET MOUNT 1352277 QUICK-LOCK SPECULUM ARM 1362275 UNIVERSAL FLEXIBLE Clip, Removable, Skin Hysteroscopy Instruments Pick, Microsurgical Ear Remover, Crown SLIDE CALIPERS OF STAINLESS STEEL SYNTHETIC MATERIALS Caliper, Clinical All-in-one Unit CAMLIGHT Navigated 4mm up angled Curette Navigated 4mm down biting Curette Navigated 6mm up angled Curette Navigated 6mm angled ring Curette Knife, Ophthalmic NAIL SPLITTING SCISSORS Cutter, Surgical Dynamometer, Nonpowered Forceps, Biopsy, Gynecological Speculum, Vaginal, Metal Vaginal Specula, and others KOGAN Endospecula, Trimmer Retractor, Selt-Retaining Scissors, Ophthalmic Instrument, Cast Removal, AC-Powered Instrument, Microsurgical Scalpel handle Syringe Snare, Nasal Snare, Non-Electrical Needle, Suturing, Reusable Suction Tube Saw Needle, Aspiration and Injection, Reusable Retractor, Non-Self-Retaining Instrument, Manual, General Surgery Accessories, Catheter House cartilage crusher Saw, Nasal Scissors, Nasal Rongeur Ferris-Smith Ronguer Kerrison Rongeur Handle for Kerrison-Rongeur, Laminectomy punch Rotatable Kerrison laminectomy punch Gordon Vulsellum Forceps SChroeder Uterine Vulsellum Kelly Vulsellum Forceps Laufe Uterine Polypus forceps Billroth Tumor FCPS Overstreet Endo Polyp Forceps Henrotin Vul Forceps Somers Uterine Elev Forceps Long Hysterectomy Forceps Museux Uterine Vulsellum Jacobs Uterine Vulsellum Teale vulsellum forceps Instrument, Ligature Passing & Knot Tying Depressor, Metal Tongue, ENT PROBE Clamp, Penile Adenotome Specula, Ophthalmic WORKTABLE 1352285 HUBBARD W/BRACKET Rack, Clip Cutter, Ring Trimmer Instruments, Manual, General Obstetric-Gynecologic SIL OSTEO W/GRD 6-3/4 STR 4MM SIL OSTEO W/GRD 6-3/4 RT 4MM SIL OSTEO W/GRD 6-3/4 LT 4MM 8mm Osteotome straight TYMPANUM KNIVES HYSTERECTOMY FORCEPS uterine forceps Drills Instrument, Cutting, Orthopedic Joker Elevator ORTHOPEDIC MANUAL SURGICAL Scalpel Holder Instrument, Orthopedic, Manual Surgical Dressing Forceps Thread Clip House Mess-Sonde Hook, Microsurgical, Ear Halter, Head, Traction ELEVATOR Elevator, ENT Mallet PERCUSSION HAMMERS Hook, Ophthalmic Dilator, Lachrymal Stripper, Surgical JACKSON TRACHEAL BISTOURY, 7, CURVED BLADE Freeman Areola Markers, Grossman Areola Markers McKissock Breast Markers, Marker, Skin Cutter, Wire Uterine Tenaculum Forceps FORCEPS Forceps, Rongeur, Surgical PHANEUF CLAMP CURVED 8 1/2" Uterine Vulsellum Forceps, Various Models Forceps, Surgical, Gynecological Dissector, Tonsil Contractor, Surgical Retractor, Ophthalmic Snare, Ear ossicle holding clamp MICRO-WORKTABLE OSSICLE HOLDING CLAMP Osteotome, Manual Guide, Surgical, Instrument Accessories, Arthroscopic Bowl stainless steel Speculum, ENT Clamp, Cannula Hook, Tracheal TENDON PASSING INSTRUMENTS Passer Gall stone scoop Scissors, Umbilical Ostium Seeker MINI BULLDOG STRAIGHT 4MM MINI BULLDOG STRAIGHT 6MM MICRO BULLDOG STRAIGHT 7MM MINI BULLDOG CURVED 7MM MICRO BULLDOG ANGLED 9MM SAROT ARTERY CLAMP MED 7 1/2" MICRO BULLDOG APPLYING FORCEP MICRO BULLDOG SLIGHT CURVE 9MM MICRO BULLDOG STRAIGHT 8MM Forceps, ENT Elevator Down pushing curette 4mm Penfield, 2mm, pull, straight Navigated Curette Curette Needle, Gastro-Urology Dilator, Tracheal APPLYING AND REMOVING FORCEP Applier, Hemostatic Clip Clamp, Circumcision, Bell Brushes Ellik Evacuator Tube to Ellik Evacuator Connector Stopcock with male luer lock Retractor, Vaginal RETAL SPECULA Clamp, Surgical, Gen. & Plast. Surg. Skene, Staude-Moore, Czerny, and other models Schroder, Teale, Jakobs, Museux Duplay, Schroder-Braun, Braun, Tenaculum, Uterine Scissors, Surgical Tissue, Dental Spatula, Surgical, Gen. & Plastic Surgery Snare, Tonsil Derlacki Mobilizer Sound, Uterine Curette Arthroscope Endoscope sleeve Kerrison-Rongeur Remover, Intrauterine Device, Contraceptive, hook-Type Sponge and Dissecting Forceps Dissecting Forceps, with ratchet Grasping Forceps, S-shaped Catheter Punch Stylet Sound, Urethral, Metal or Plastic Curette-Excavator HOUSE CUR 7 D/E STRG-ANG HOUSE STAPES CUR 6 D/E ANG 35D HOUSE CUR 7 D/E LGHT-ANG Spud, Ophthalmic Screwdriver Dilator, Cervical, Fixed Size Curette, Uterine Retractor, ENT Saw, Electrically Powered Tuning Fork NEUROLOGICAL PINWHEEL Trocar, Tracheal Instruments, Dental Hand SPATULA/PACKER AND OTHERS MATRIX WAXER HEBU Micro Suction Tubes ROSEN SUCTION TUBE BARON SUCTION TUBE Tube, Ear Suction Loop, Wire Instruments, Surgical, Cardiovascular Ligator HEBU Neuroline Suction Tubes Micro Vessel Knives, F5-9009-000 Instruments, Surgical, Non-Powered Gauge, Depth, Instrument, Dental Ring, Laparotomy Rasp, Nasal Bending Iron Amniotom Beacham, 26cm, 10 1/4" Surgical Instruments, G-U, manual (and accessories) Drills, Burrs, Trephines & Accessories (Manual) Teflon cutting block Twister, Wire TONSILLECTOME Knife, Tonsil Curette, Ear EAR CURETTES (DIFFERENT MODELS) Forceps, Gen. & Plastic Surgery WIDE RANGE OF GEN. PLASTIC SURGERY FORCEPS Reduction Forceps Nail instruments Fox Ball Tip Feeler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2009-03-03
HBD	Handpiece (Brace), Drill	Neurology	Class 1	882.4325	2017-02-02
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2012-02-16
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-03-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-03-19
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-05-01
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1979-05-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-09-09
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1999-10-25
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2010-10-26
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-17
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-17
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2025-06-17
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-17
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-06-17
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2015-04-10
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2015-04-10
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-01-25
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2020-06-24
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2015-04-10
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2000-02-22
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-10-25
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2021-11-11
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2025-12-05
HDM	Packer, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2013-01-25
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	1999-10-25
HWB	Extractor	Orthopedic	Class 1	888.4540	2012-02-16
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2012-07-02
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-01-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-04-30
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-16
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2020-08-26
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2018-07-24
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2013-01-25
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2010-03-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2025-12-05
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2016-11-24
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2011-02-23
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-04-17
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1999-10-25
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2005-12-07
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	2020-06-24
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	1999-12-10
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2026-01-07
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2000-06-05
EIS	Remover, Crown	Dental	Class 1	872.4565	2011-09-07
KTZ	Caliper	Orthopedic	Class 1	888.4150	1999-10-25
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2026-04-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-05-23
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-10-25
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-06-05
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	1999-10-25
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1979-05-09
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2000-05-01
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2024-07-23
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1999-12-10
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1979-05-09
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2000-05-01
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2000-05-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-04-10
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2015-04-23
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	1999-12-10
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2000-05-01
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2015-02-23
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2000-06-05
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2000-06-05
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2000-05-01
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-04-23
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-07-20
JYW	Press, Vein	Ear, Nose, Throat	Class 1	874.4420	2017-09-21
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
HTX	Rongeur	Orthopedic	Class 1	888.4540	1979-05-09
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2014-04-17
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1999-12-10
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2000-02-22
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2000-06-05
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-02-22
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2020-07-28
HBR	Rack, Clip	Neurology	Class 1	882.4215	1999-12-10
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2000-05-01
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2024-07-25
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2012-01-25
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2014-03-14
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	1999-10-25
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2017-03-17
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-06-05
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1999-12-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2001-11-06
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2019-11-07
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
HSS	Halter, Head, Traction	Orthopedic	Class 1	888.5890	1999-12-10
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1999-10-25
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-02-22
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2000-02-22
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2000-06-05
KCC	Bistoury, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2020-10-22
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2009-07-20
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2010-11-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-05-27
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2001-08-25
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2010-03-24
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-05-01
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-02-22
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
JYF	Clamp, Ossicle Holding	Ear, Nose, Throat	Class 1	874.4420	2015-04-23
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-16
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2010-09-09
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2023-11-30
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1999-05-18
FKC	Clamp, Cannula	Gastroenterology, Urology	Class 1	876.5540	2013-01-25
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
HWQ	Passer	Orthopedic	Class 1	888.4540	2000-06-05
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2014-03-14
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2000-05-01
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2017-09-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-05-05
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1979-05-09
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-01-25
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-01-31
FHR	Needle, Gastro-Urology	General, Plastic Surgery	Class 1	878.4800	2000-05-01
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	1979-05-09
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	1999-12-10
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2026-03-06
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-03-28
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2013-01-25
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	1999-12-10
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-10-25
HDC	Tenaculum, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2008-06-05
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1979-05-09
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-11-04
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
KAJ	Mobilizer, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-11-28
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2000-05-01
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2015-04-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-05-27
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2000-05-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-05-27
FEX	Instrument, Catheter, Punch	Gastroenterology, Urology	Class 1	876.5090	2019-11-14
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-07-22
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2013-01-16
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-11-04
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-16
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2000-05-01
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2000-05-01
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1979-05-09
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-02-23
DWI	Saw, Electrically Powered	General, Plastic Surgery	Class 1	878.4820	2012-02-16
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2015-04-23
GWY	Pinwheel	Neurology	Class 1	882.1750	1999-10-25
KCI	Trocar, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2005-12-07
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2009-03-20
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2000-05-01
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2000-05-01
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2014-11-28
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1999-10-25
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2013-01-25
FHI	Ring, Laparotomy	Gastroenterology, Urology	Class 1	876.4730	2013-01-16
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2022-10-17
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2015-12-11
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2011-02-23
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2012-03-29
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2015-06-15
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2012-04-19
KCA	Tonsillectome	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1999-10-25
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2000-02-22
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-05-09
HXB	Probe	Orthopedic	Class 1	888.4540	2021-07-14

Official Correspondent

THOMAS BUTSCH

US Agent Details

Randolph Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

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HEBUMEDICAL GMBH

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number	Establishment Name	Location
3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
3006517555	Tonglu Youshi Medical Instrument Co.,Ltd	Tonglu Zhejiang, CN
3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611112. Last updated year: 2026. Please use registration number 9611112 when referencing this establishment in official correspondence.