17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856062429·FIXED BRIDGE, 22mm
Disc Prep
FDA UDI
Life Spine, Inc.·00190837090067·
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105922·3.5mm Locking Medial Distal Tibial Plate, 10 Ho...
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
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 14, 2013
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 25, 2011
LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008
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
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