10 results
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26ms
·
Sources: EU EUDAMED, US FDA
CARPENTER BONE CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136643·KIT, IWB TQ HOLDER w' CAT - BLK
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471182420·.022 U/L Std. Weld Size #18
OTOGRAM, CA3350
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Scanostics UTI Check Application Test System
FDA 510(k)
FDA Class 1
·Clinical Chemistry
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 28, 2014
UNKNOWN DEPUY SZ 2.5 16MM CR TIB INSERT
FDA Adverse Event
Injury
·Product code JWH·October 3, 2012
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·July 19, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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