533 results
·
21ms
·
Sources: EU EUDAMED, US FDA
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743670·ACHIMED ACHILLES SUPP SILVER IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743557·LEVAMED ANKLE SUPPORT SILVER IV
LEONE SPA
FDA UDI
LEONE SPA·08033707065869·EXTRAORAL ELASTICS 3/16" 14 oz
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036027858·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023970·PADDLE SPREADER, 14MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102140·Shaver, Open 14mm
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDIAL ROTATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FORTIFY ASSURA DR, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013
ETS LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 16, 2011
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.
FDA Enforcement
Class II
·Terminated·Nobel Biocare Usa Llc·November 20, 2013
MEDIAL ROATION KNEE
FDA Adverse Event
Injury
·MATORHTO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026