Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010155661

FEI Number

3010155661

Entity Name

Synergy Health Sterilisation UK Ltd

City/State/Country

Thorne Doncaster, GB

Establishment Address

Unit 1, Alpha Court, Capital Park, Thorne Doncaster DN8 5TZ, GB

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 10042227)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Insulet5490 (SZ) - PodPals Adhesive Overlay Bedal12006 (ED,VL2) - Bedal Flex XS, Bedal Flex S, Bedal Flex M Xiros8315 (DV) - Rigid Probe (202-3023), Malleable Probe (202-3026) FirstWater14138 (RG,SE) - Medela Breast Pads (USA) FirstWater14138 (RG) - 73230-02 - Leukomed Control Sterile FirstWater14138 (RG) - 73230-03 - Leukomed Control Sterile FirstWater14138 (RG) - DUP86466-9 - Xtrasorb HCS Adhesive FirstWater14138 (RG) - Russell Chest Seal FirstWater14138 (RG) - DUP86322-9 Xtrasorb HCS FirstWater14138 (RG) - 73230-05 - Leukomed Control Sterile FirstWater14138 (RG) - CWL 1008 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1005 - KerraLite Cool FirstWater14138 (RG) - Curad Soothe & Cool Dressing (56 x 26mm) FirstWater14138 (RG) - CWL 1009 - KerraLite Cool Border FirstWater14138 (RG) - 6030-4156 - Glaciergel FirstWater14138 (RG) - CWL 1004 - KerraLite Cool FirstWater14138 (RG) - 73230-00 - Leukomed Control Sterile FirstWater14138 (RG) - CVS86433-9 Xtrasorb HCS Non- Adhesive 3""x3"" (cvs) FirstWater14138 (RG) - 40-2979 - Hydrogel Dressing FirstWater14138 (RG) - DUP86344 - Xtrasorb HCS 4.5" X 4.5" FirstWater14138 (RG) - DUP86388-9 - Xtrasorb HCS Non- Adhesive FirstWater14138 (RG) - 6030-4157 - Glaciergel FirstWater14138 (RG) - 73230-01 - Leukomed Control Sterile FirstWater14138 (RG) - Curad Soothe & Cool Dressing (74 x 45mm) FirstWater14138 (RG) - CWL 1007 - KerraLite Cool Border FirstWater14138 (RG) - CWL 1006 - KerraLite Cool Phagenesis8358 (TH) - Phagenyx System DORC10527 (VL1) - Scissors, Ophthalmic BlinkMedical8355 (TH) - Surgical Forceps Ambu10292 (KK) - aScope BronchoSampler 60 SC Klinika34754 (VL2) - Container, Specimen, Sterile Haag17033 (TH) - TONOSAFE STERILE DISPOSABLE PRISM Arrotek8349 (TH) - Solo+ Tympanostomy tube Device (TTD) Newclip11561 (MS) - KEMIS H,3 Knife Crega6530 (TH) - GORE® DrySeal Flex Introducer Sheath BlinkMedical8355 (TH) - Surgical Manipulation Instruments DORC10527 (VL1) - Forceps, Ophthalmic Xiros8315 (DV) - CC-Hook BlinkMedical8355 (TH) - Hook, Surgical, General & Plastic Surgery StrykerTrauma (RB) - Scalpel LakeRegion8374 (TH,TL) - Lake Region Axessio GoldenSeason (KK) - NAR COMPRESSED GAUZE; NAR S-ROLLED GAUZE; NAR Z-FOLD GAUZE AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PACAT0 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PXCAT0 AutonoMeTM Automated Pre- loaded Delivery System (CCATT3-T6) AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CNAET0 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CCAET3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PACAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre-loaded Delivery System PXYAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre-loaded Delivery System PAYAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CCAET0 Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive IVF8650 (DK) - TRAUMA BANDAGE FirstWater14138 (RG) - F12LB/648/C1/2 Dr Scholl's Blister Cushion Dressing FirstWater14138 (RG) - F10LB/599/G2/2 Dr Scholls Corn Cushion - New Liner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2013-03-22
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-03-22
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2013-03-22
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2013-03-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-03-22
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2013-03-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2013-03-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-01-16
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-09-13
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2015-04-29
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-03-22
HXB	Probe	Orthopedic	Class 1	888.4540	2020-11-30
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2018-06-18
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2013-03-27
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2013-02-07
QQG	Oropharyngeal Electrical Stimulator	Ear, Nose, Throat	Class 2	874.5950	2024-07-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-11-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-01
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2013-01-16
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2014-07-04
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2020-11-30
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2026-06-08
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2026-06-08
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2017-01-16
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2020-11-30
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-16
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2018-06-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-03-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-03-25
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-02-20
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2020-05-26
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2013-03-22
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-12-10
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2023-01-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-01
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2014-12-23
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2013-09-05
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2023-11-20
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-11-20
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-11-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-11-20
KGY	Bag, Intestine	General, Plastic Surgery	Class 1	878.4100	2013-03-21
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2020-11-30
OJK	Eye Tray	Ophthalmic	Class 2	886.4790	2025-12-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-10-31
PWL	Oral Surgery Tray	Dental	Class 1	872.4565	2020-05-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-01-01
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-11-30
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-11-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-22
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-16
ETD	Tube, Tympanostomy	Ear, Nose, Throat	Class 2	874.3880	2025-02-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-03-22
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-19
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2020-02-20
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2019-11-11
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2019-09-04
MLS	Labor And Delivery Kit	Obstetrics/Gynecology	Class 2	884.4530	2020-11-30
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-03-22
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2013-03-22
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2015-04-29
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-06-08
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2016-08-02
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2017-02-27
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-11-11
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2019-06-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-01-08
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2026-01-08
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2020-05-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-22
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-11-30
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2020-05-26
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2020-02-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-01-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-01-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-12-30
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2020-01-14
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2020-11-30
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2020-02-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-10-22
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2020-06-16
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-03-22
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2013-01-16
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2015-08-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-22
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2020-11-30
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-06-18
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2013-01-16
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2020-11-30
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2020-05-26
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2023-11-03
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2023-11-03
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-11-03
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2020-05-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-03-03
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2013-03-18
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2020-12-08
EFN	Cotton, Roll	Dental	Class 1	872.6050	2020-11-30
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-19
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2020-02-20
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-01-01
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2013-03-20
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2015-06-01
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-18
EIG	Retractor, All Types	Dental	Class 1	872.4565	2020-02-20
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-11-11
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2020-02-20
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2021-03-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2021-03-06
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2021-03-06
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-06-18
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2013-01-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2015-09-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-06-23
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2016-11-12
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2026-06-08
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2019-11-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-10-22
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2020-11-30
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-01-10
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2020-05-26
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-03-01
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2021-02-05
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2021-02-05
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	Class 3	886.3600	2021-02-05
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2021-02-05
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-11-20
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2013-03-01
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2013-03-01
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	Gastroenterology, Urology	Class 2	876.4020	2013-01-16
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-06-18
PVX	Vaginal Examination Tray	Obstetrics/Gynecology	Class 2	884.4530	2020-11-30
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-22
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-01-01
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-01-16
NYC	Dental Prophylaxis Kit	Dental	Class 1	872.4565	2020-05-26
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-03-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-11-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-11-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-12-20
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2020-02-20
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-02-20
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2018-05-31
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2020-05-26
LNR	System, Photopheresis, Extracorporeal	Unknown	Class 3	N/A	2018-03-12
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2019-02-07
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2019-11-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-01-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-11-02
PUA	Tenaculum, Uterine, Exempt	Obstetrics/Gynecology	Class 2	884.4530	2020-02-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2016-01-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-09-20
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2020-05-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-01-24
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2018-11-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-12-21
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-11
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2019-03-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-11-20
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2023-11-20
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2013-03-25
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-03-25
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2013-03-25

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873288	Todd Medical, Inc.	CLOSED FOLEY CATHETER SYSTEM	1987-11-27
K912919	Mentor Corp.	MENTOR INFUSION LINE	1991-12-13
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010155661. Last updated year: 2026. Please use registration number 3010155661 when referencing this establishment in official correspondence.