16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHANTOM PLUS CERAMIC CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-
FDA 510(k)
FDA Class 2
·Cardiovascular
BRIGHT GOLD
FDA 510(k)
FDA Class 2
·Dental
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
TARGETING ARM PROX. LAT. TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
ALT HA S CLR EXT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·November 14, 2023
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 15, 2013
PINNACLE SECTOR II CUP 56MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 9, 2011
MTOME ST HOLSTER/CABLES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code KNW·August 13, 2008
NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 31, 2024
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 12, 2024
BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 3, 2024
PLATE ADAPTER DIST. LAT. FEMUR RIGHT
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·May 11, 2017
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
FDA Enforcement
Class I
·Ongoing·Ventec Life Systems, Inc.·March 5, 2025
NV GXL LINER LIPPED 36MM ID GROUP 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·November 1, 2022