18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
4200
FDA UDI
HANS RUDOLPH, INC.·00874750008391·4200A .875FB 22mmOD x 22mmID
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122230·KWire .045x9" (1.1x225mm)
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235489·Anchor Template, Long
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235472·Anchor Template, Short
V-14 CONTROL WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DQX·October 27, 2022
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NANOCERAM- BRIGHT
FDA 510(k)
FDA Class 2
·Dental
EP DIAGNOSTIC CATHETER EP XT STEERABLE DECAPOLAR LARGE 4.0
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NLH·October 5, 2020
ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·March 12, 2026
ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·March 11, 2026
ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·March 11, 2026
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 3, 2013
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·September 23, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·April 29, 2011
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021