15 results
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26ms
·
Sources: EU EUDAMED, US FDA
Lyra Influenza A+B Assay
FDA 510(k)
FDA Class 2
·Microbiology
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780165491·Integra® Jarit® Stille-Luer Rongeur, 10", 10mm ...
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·October 18, 2016
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
UNKNOWN DEPUY FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·November 12, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 1, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
NEU_INS_STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 23, 2012
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·October 31, 2022
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·October 31, 2022
Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin and either an 18-gauge or a 19-gauge 5 micron filter needle. Ref: IVT-KIT-29G
FDA Enforcement
Class II
·Ongoing·Apellis Pharmaceuticals, Inc.·October 11, 2023
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025