STERIS SPA

FDA Device Registration & Listing · CALCINATE Bergamo, IT · Registration 3002806603

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002806603
FEI Number
3002806603
Entity Name
STERIS SPA
City/State/Country
CALCINATE Bergamo, IT
Establishment Address
3, 5, 7, 9, VIA EINAUDI, CALCINATE Bergamo 24050, IT
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ulrich (CC) - ulricheasyINJECT Max Microport (CC) - PLATINIUM DR 1510 Microport (CC) - PLATINIUM VR 1240 Microport (CC) - PLATINIUM DR 1540 Microport (CC) - PLATINIUM VR 1210 Jabil8683 (DK) - CONFIDENCE Spinal Cement System LimaCorpSPA9283 (CC,SR) - Physica system LimaCorpSPA9283 (CC) - Physica system Microport (CC) - ALIZEA SR 1300 Microport (CC) - CELEA SR 1100 Microport (CC) - CELEA DR 1400 Microport (CC) - ESPRIT SR Microport (CC) - REPLY DR Microport (CC) - ESPRIT DR Microport (CC) - REPLY SR Microport (CC) - Accessory for pacemaker, ICD and CRT-D Screw driver Microport (CC) - ALIZEA DR 1600 LimaCorpSPA9283 (CC) - CMD 24-1336 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1494 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1278 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1568 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1298 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1441 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1396 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1417 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1454 Promade Hip LimaCorpSPA9283 (CC) - CMD 24-1439 Promade Hip LimaCorpSPA9283 (CC) - CMD 24-1434 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1137 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1491 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1586 ProMade Hip LimaCorpSPA9283 (CC) - SMR 3-Pegs Small LimaCorpSPA9283 (CC) - SMR 3-Pegs Standard LimaCorpSPA9283 (CC,SR) - SMR TT Augmented Glenoid System LimaCorpSPA9283 (CC, SR) - Cemented cups; Lock Bipolar heads; Modular heads; Modulus femoral stems LimaCorpSPA9283 (CC,SR) - Physica KR knee system LimaCorpSPA9283 (CC) - SMR Modular Glenoid Quanta (CC) - EMP-FBX200BHS, EMP-FBX200BHS-C Quanta (CC) - EMP-FBX200HS, EMP-FBX272HS, EMP-FBX365HS, EMP-FBX550HS, EMP-FBX1000HS, EMP-FBX272HS-C Quanta (CC) - EMP-FBX200HR, EMP-FBX272HR, EMP-FBX365HR, EMP-FBX550HR, EMP-FBX1000HR, EMP-FBX272HR-C Ulrich (CC) - ulrichINJECT CT motion LimaCorpSPA9283 (CC,SR) - Bone screws 5mm LimaCorpSPA9283 (CC) - CMD 24-1584 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1137 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1207 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1075 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1271 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1238 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1131 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1446 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1603 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1053 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1362 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1008 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1228 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1416 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1641 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1402 ProMade Hip LimaCorpSPA9283 (CC) - CMD 24-1610 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1313 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1081 ProMade Hip LimaCorpSPA9283 (CC) - CMD 25-1083 ProMade Hip LimaCorpSPA9283 (CC) - SMR Reverse Liner Stirilab11801 (VB) - EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE LimaCorpSPA9283 (CC,SR) - SMR Shoulder System Sterylab (CC) - MRX-Mammorep XJ Sterylab (CC) - CCH-Complete Chiba Sterylab (CC) - FLP-Full-opty Sterylab (CC) - R-MLC1825 Sterylab (CC) - SPG-Spring-cut Sterylab (CC) - VCS-needle set Sterylab (CC) - R-BEN1110 Sterylab (CC) - MRZ-Mammorep Zeta Sterylab (CC) - CCH-CompleteChiba Sterylab (CC) - R-MLC1415 Sterylab (CC) - MRN-Mammorep Sterylab (CC) -MCN-MieloCan Sterylab (CC) - BSL-Best Lisa needles Sterylab (CC) - ATA-CUT Sterylab (CC) - MRZ-MammorepZeta Sterylab (CC) - BEST-BTT Sterylab (CC) - MCN-Mielocan Sterylab (CC) - R-FSC1825B Sterylab (CC) - ECX-Echochiba Sterylab (CC) - R-ACG1411 Sterylab (CC) - BEN-Bone Marrow needle Sterylab (CC) -MAMMOREP-LOOP Sterylab (CC) - R-MLC1820 Sterylab (CC) - FSC-FAST CUT Sterylab (CC) - R-MCN22 Sterylab (CC) - R-FSC1820B Sterylab (CC) -MLC-MultiCore Sterylab (CC) - CLT-Colt Sterylab (CC) - R-MRN2115 Sterylab (CC) -MRN-Mammorep Sterylab (CC) - BIO-CUT Sterylab (CC) - VCS-Needle set Sterylab (CC) - FSC-Fast Cut Sterylab (CC) - R-MRN2109 Sterylab (CC) - AGO-GUIDA Sterylab (CC) - PAG-Paragon Sterylab (CC) - R-MRN2106 Sterylab (CC) - R-CLT1411 Sterylab (CC) -MRX-Mammorep XJ Sterylab (CC) - SPG-SpringCut Sterylab (CC) - FLP-Full Opty Sterylab (CC) - R-AGC1411 Sterylab (CC) - BEST Sterylab (CC) - R-MRN2111 Sterylab (CC) - MLC-Multicore Sterylab (CC) - R-MLC1411 Sterylab (CC) - HEPA-CUT Quanta (CC) - OAF006011, OAF008001, OFA008011, OAF009901, OAF009911, OAF102791, OAF402011, OAF402711 Quanta (CC) - OAF002011, OAF002701, OAF002711, OAF003601, OAF003611, OAF005501, OAF005511, OAF006001 Quanta (CC) - OAF302711, OAF302721 Quanta (CC) - OAF002001 Quanta (CC) - OAF702701, OAF702711, OAF702791 Quanta (CC) - OAF103611 Quanta (CC) - OAF103691, OAF102711, Quanta (CC) - OAF703601, OAF703611, OAF703691 Plan1Health (CC) - PAINfusor catheter LimaCorpSPA9283 (CC,SR) - Minima S System Corcym (CC) - Single Use MICS Accessory Kit Corcym (CC) -Dual MICS Holder Corcym (CC) - Perceval RelyON PAK accessories kit Corcym (CC) - Single Use Accessory Kit Corcym (CC) - Dual Holder Corcym (CC) -Dual Collapser Corcym (CC) - Post-dilation Catheter LimaCorpSPA9283 (CC,SR) - SMR Shoulder System LimaCorpSPA9283 (CC) - CMD 24-1393 ProMade Hip LimaCorpSPA9283 (SR,CC) - C2 Femoral Stem LimaCorpSPA9283 (CC,SR) - SMR Shoulder System LimaCorpSPA9283 (SR,CC) - Delta Dual Mobility System LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1253 ProMade Shoulder; CMD 25-1274 ProMade Shoulder; CMD 25-1336 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1223 ProMade Shoulder; CMD 25-1233 ProMade Shoulder; CMD 25-1248 LimaCorpSPA9283 (CC) - CMD 24-1132 Promade Shoulder LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1456 ProMade Shoulder; CMD 24-1457 ProMade Shoulder; CMD 24-1470 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1375 ProMade Shoulder; CMD 24-1380 ProMade Shoulder; CMD 24-1410 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1616 ProMade Shoulder; CMD 24-1620 ProMade Shoulder; CMD 24-1629 LimaCorpSPA9283 (CC) -CMD 24-1132 Promade Shoulder; CMD 24-1224 ProMade Shoulder; CMD 24-1240 ProMade Shoulder; CMD 24-1 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1542 ProMade Shoulder; CMD 24-1556 ProMade Shoulder; CMD 24-1592 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 24-1481 ProMade Shoulder; CMD 24-1486 ProMade Shoulder; CMD 24-1509 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1165 ProMade Shoulder; CMD 25-1176 ProMade Shoulder; CMD 25-1217 LimaCorpSPA9283 (CC) -ProMade Shoulder; CMD 24-1423 ProMade Shoulder; CMD 24-1429 ProMade Shoulder; CMD 24-1446 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1136 ProMade Shoulder; CMD 25-1151 ProMade Shoulder; CMD 25-1164 LimaCorpSPA9283 (CC) - ProMade Shoulder; CMD 25-1024 ProMade Shoulder; CMD 25-1038 ProMade Shoulder; CMD 25-1042 ProMade LimaCorpSPA9283 (CC) -ProMade Shoulder; CMD 25-1079 ProMade Shoulder; CMD 25-1110 ProMade Shoulder; CMD 25-1111 LimaCorpSPA9283 (CC) - CMD 24-1240 ProMade Shoulder Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Lima9283 (CC,SR) - Prima TT Glenoid LimaCorpSPA9283 (CC) - LimaCorpSPA9283 LimaCorpSPA9283 (CC) - Revision Femoral Head LimaCorpSPA9283 (CC) - Physica system LimaCorpSPA9283 (CC,SR) - PRIMA Humeral System LimaCorpSPA9283 (CC,SR) - SMR Lateralized connectors with screws Lima9283 (CC,SR) - SMR Stemless Anatomic LimaCorpSPA9283 (CC) - Physica CR Knee System LimaCorpSPA9283 (CC) - SMR 3-Pegs Glenoids LimaCorpSPA9283 (CC,SR) - Delta Liners; Delta TT Cups Microport (CC) - PLATINIUM CRT-D 1711 Microport (CC) - PLATINIUM CRT-D 1741 Microport (CC) - PLATINIUM 4LV CRT-D 1744 LimaCorpSPA9283 (CC,SR) - SMR Shoulder System Summit (DV) - Medium Port MiniMix Bone Cement Mixing System SMMM1 Summit8301 (DV) - Mixing Bowl, Spatula B710 Summit8301(DV) - HiVac Bowl Bone Cement Mixing System B713 LimaCorpSPA9283 (CC,SR) - Delta TT Pro LimaCorpSPA9283 (CC,SR) - Revision Bone Screw LimaCorpSPA9283 (CC,SR) - Bone Screw LimaCorpSPA9283 (CC,SR) - Locking Bone Screw Hemodia (CC) - DOUBLEFLO LimaCorpSPA9283 (CC) - PRIMA TT Glenoid LimaCorpSPA9283 (SR) - PRIMA Humeral System; PRIMA TT Glenoid Quanta (CC) - OAF506011, OAF506001, OAF506091 Quanta (CC) - OFA001511

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-03-08
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-03-08
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2024-09-23
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2026-05-13
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2026-05-13
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2026-05-13
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2026-05-13
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2024-07-15
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2024-07-15
MRM Defibrillator, Implantable, Dual-Chamber Unknown Class 3 N/A 2024-07-15
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2024-07-15
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2023-01-18
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-11-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-11-27
LOD Bone Cement Orthopedic Class 2 888.3027 2022-11-27
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2022-11-27
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2013-01-22
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2021-01-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-01-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-01-19
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2024-12-19
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2022-12-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-12-14
IWP Radiographic Protective Glove Radiology Class 1 892.6500 2020-01-15
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2024-07-15
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2024-07-15
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2024-07-15
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2013-03-22
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2025-02-21
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-11-08
HRX Arthroscope Orthopedic Class 2 888.1100 2025-03-14
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2025-03-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-01-17
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2020-01-17
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-01-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-01-17
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2017-01-31
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2017-01-31
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-01-31
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2017-01-31
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-12
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2022-12-22
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-02-01
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2017-02-01
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2015-05-06
HRX Arthroscope Orthopedic Class 2 888.1100 2015-05-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2017-02-01
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2017-02-01
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2025-12-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-04-05
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2018-10-17
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-12-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-14
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-12-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-12-22
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2021-02-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-04-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-12-22
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2016-11-12
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-11-20
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-12-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-14
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2022-12-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-14
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-12-14
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-03-27
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2023-03-27
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2013-01-17
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2013-07-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2015-11-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-12
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2014-11-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2014-11-08
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2023-01-10
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-01-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-04-05
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2020-01-13
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2020-12-09
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2017-01-31
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2017-01-31
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-01-31
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2017-01-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-01-31
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2017-01-31
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2016-02-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2014-11-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-11-08
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-03-07
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-11-20
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2020-01-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-01-17
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2020-01-17
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2021-02-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-11-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-03-27
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2025-12-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-01-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-01-17
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2020-01-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-02-21
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2014-11-12
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-03-27
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2019-03-10
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-01-08
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2024-01-08
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-03-14
HXY Brace, Drill Orthopedic Class 1 888.4540 2016-12-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-01-31
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2021-01-31
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-11-20
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-11-20
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2021-02-10
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-12-14
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2022-12-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-12-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-12-14
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2022-12-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-12-14
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2023-01-18
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-01-17
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-01-17
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2020-01-17
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-01-17
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-01-08
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2017-02-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2017-02-01
EXQ Cystometer, Electrical Recording Gastroenterology, Urology Class 2 876.1620 2024-12-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2014-11-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-11-08
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2024-07-16
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2024-07-16
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2024-07-16
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2024-07-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-11-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2014-11-08
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2012-12-20
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-01-17
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2020-01-17
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-03-27
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2017-01-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-03-08
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-11-20
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-11-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-12
HRX Arthroscope Orthopedic Class 2 888.1100 2023-01-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-11-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-11-12
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-11-12
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2025-02-21
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2025-02-21
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-02-21
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2025-02-21
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2025-02-21
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2025-02-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-04-05

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
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28
K202800 Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Pacific Plus PTA Catheter 2020-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number Establishment Name Location
3011142981 Rontis Hellas S.A. Larisa Thessalia, GR
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3005994106 Creagh Medical Ltd. Co. Galway, IE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806603. Last updated year: 2026. Please use registration number 3002806603 when referencing this establishment in official correspondence.
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