9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EXTERNAL FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902958755·TRIAL 974-911 LORD 9X11X11
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2014
QUICK COUPLING FOR K-WIRES
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·February 22, 2013
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Malfunction
·LEICA BIOSYSTEMS MELBOURNE PTY LTD·Product code IEO·January 13, 2011
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
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