11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZAVATION SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
9300
FDA UDI
HANS RUDOLPH, INC.·00874750008919·9315 SUB/MATES 1410/9301 HCNTL
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SEQURE SNARE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·May 14, 2013
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTR·April 4, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
CDI H/S CUVETTE
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS·Product code DRY·January 5, 2016
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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