16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straumann PUREloc abutments
FDA 510(k)
FDA Class 2
·Dental
Bernafon
FDA UDI
Bernafon AG·05711584087497·ZR1, KIT 10 NFM 75 PB BE ZERENA 1
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199944·Wesiman Pederson Speculum insulated medium
PEAK PULSAR II GENERATOR MODEL PS100-102
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
FDA 510(k)
FDA Class 2
·Anesthesiology
PEN NEEDLE 32G 4MM 5B XTW 100CT EU
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 30, 2025
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·February 26, 2025
ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 19, 2016
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 1, 2016
PFC SIG RPF CEM FEM SZ 2 LT
FDA Adverse Event
Injury
·DEPUY-RAYNHAM - A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTN·June 20, 2013
ONE-LINK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 28, 2025
ONE-LINK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 28, 2025
JUGGERSTITCH CURVED IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·August 26, 2024
JGRKNT 1.0MM MINI 3-0 NDLS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code MBI·May 27, 2025