9 results
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18ms
·
Sources: EU EUDAMED, US FDA
FEMORAL CEMENT REMOVAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·Orthopedic
GC Initial™
FDA UDI
Gc America Inc.·J0228702171·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...
GC Initial™
FDA UDI
Gc America Inc.·15400556703653·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
FDA 510(k)
FDA Class 2
·Neurology
LANCE LTD. STERI. STITCH CUTTER BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR·Product code FWM·June 6, 2014
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·December 12, 2012
OMNISPAN MENISCAL FASTENER
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·October 11, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024