40 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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Phantom Tibial Preparation
FDA UDI
ADLER ORTHO SPA·08052693623556·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.6
16PW - Krispy Kreme FAK - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White
A-CIFT® SoloFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361021575·A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic...
BD SYRINGE 10ML LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 9, 2017
HORIZONS HOT BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WMT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sientra OPUS Silicone Gel Breast Implant Sizer
FDA 510(k)
FDA Unclassified
·Unknown
13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 30, 2017
13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 4, 2017
HAMILTON-C3
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024
XPOSE 4 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 4, 2011
PRESIDIO - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·October 27, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·May 8, 2013
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011