21 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
2870 3WAY SLIDE VALVE
FDA UDI
HANS RUDOLPH, INC.·00874750009008·2870K 3WAY MAN SLD VLV 1.125OD
Disc Prep
FDA UDI
Life Spine, Inc.·00190837090074·
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105939·3.5mm Locking Medial Distal Tibial Plate, 10 Ho...
MULTI-LEAD TRIALING CABLE MODEL 355531
FDA 510(k)
FDA Class 2
·Neurology
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
ECHI GREENVILLE NC 2
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011
STONYBROOK HSP NY NY 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015
ASR 300 SPIKED CUP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
C21785 IT TREVISO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code GEI·December 14, 2012
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022
BD PYXIS¿ ANESTHESIA STATION ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·July 17, 2025
WALLFLEX? BILIARY TRANSHEPATIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012
D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026