8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STRYKER 2115 REPLACEMENT BATTERY (2115)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
artegral
FDA UDI
Merz Dental GmbH·D7091970378·anteriors; shade D2; mould CM
AirLife Adult Heated Wire BiPAP/NIV Circuit
FDA 510(k)
FDA Class 2
·Anesthesiology
ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 20, 2013
ASCENSION PIP
FDA Adverse Event
Injury
·ASCENSION ORTHOPEDICS, INC.·Product code NEG·January 14, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 31, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022