16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S.I.N. Instrument Kits
FDA 510(k)
FDA Class 2
·General Hospital
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002077·External 4.0mm x 4.5mm Flared Healing Abutment
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
FDA 510(k)
FDA Class 2
·Cardiovascular
CONCENTRIC BALLOON GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021
ITREL 4
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·July 15, 2015
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 15, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 9, 2013
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
SHORELINE ACS, WAVEFORM C
FDA Adverse Event
Injury
·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023