25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Evogue Dental Unit
FDA 510(k)
FDA Class 1
·Dental
POUR-PLUS
FDA UDI
Denplus Inc·D8451152100·POUR-PLUS LIQUID, 250 ml
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036054380·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702580136·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/SLIP FORM W...
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315818897·XL CSF1R BA, Break Apart Probe
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PERMACOL
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·January 10, 2024
PERMACOL
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·January 10, 2024
TRULIANT TIB IMP PSC INSERT SZ 6, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 8, 2014
MEDTRONIC.KAPPA
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 7, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code JLW·July 7, 2011
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 24, 2024
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 14, 2023
ADVANCED PATELLA 32MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 19, 2025
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 19, 2023
ALARIS® PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION·Product code FRN·August 13, 2019
Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of cranial maxillofacial anatomy, including but not limited to brow fixation.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code JEY·March 19, 2008