17 results · 23ms · Sources: EU EUDAMED, 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