16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RISTOCETIN COFACTOR ASSAY KIT
FDA 510(k)
FDA Class 2
·Hematology
MAS PCF
FDA UDI
Nuvasive, Inc.·00887517651402·MAS PCF Screw, 4.0x14mm
TERUMO ANGIOGTAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MANGAR BOOSTER
FDA 510(k)
FDA Class 2
·General Hospital
INSERTION HANDLE F/ TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code FZX·February 1, 2013
PROXIMATE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GDW·December 22, 2010
VERSION CONTROL STEM INSERTER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·July 21, 2014
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 14, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·July 3, 2024
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·Product code DQO·November 3, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·Product code DQO·November 3, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·Product code DQO·November 3, 2020
RADIFOCUS GLIDECATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·January 24, 2023
RADIFOCUS ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·September 26, 2018
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 27, 2025
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·August 26, 2015