7 results
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36ms
·
Sources: EU EUDAMED, US FDA
COAT-A-COUNT INSULIN KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REMSTAR PRO WITH C-FLEX CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·November 6, 2012
OXF UNI TIB TRAY SZ D RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·June 5, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022