17 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550179·GENUMEDI PT KNEE SUP SILVER R EW III
INOmax DSIR Plus MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550193·GENUMEDI PT KNEE SUP SILVER R EW IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961432130·Sinus Lift Curette
round ...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221038197·Unitek(TM) Bicuspid Band General Purpose Narrow...
KOWA VX-10
FDA 510(k)
FDA Class 2
·Ophthalmic
FINESS ENDOSCOPE STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014
REMB MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·June 3, 2013
1X2 CDP PM KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·June 28, 2011
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 2, 2018
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)
FDA Recall
Open, Classified
·American Contract Systems Inc.·Product code OJH·September 4, 2025
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017