16 results · 23ms · Sources: EU EUDAMED, US FDA

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IntelliVue Patient Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Masel

FDA UDI
Ortho Organizers, Inc.·00190707041144·Choice™ Tweed Loop Forming Pliers

ProLift

FDA UDI
Life Spine, Inc.·00190837106461·Static Expandable Cage Trial, 10mm x 28mm x 10m...

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100585·LIEBERMAN TEMPORAL SPECULUM K-WIRE

TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

FDA 510(k)
FDA Class 2 ·Cardiovascular

DERMILLUME RED, MODEL HR1000

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD CONNECTA¿ STOPCOCK

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·January 3, 2019

ORS-320N SOLUTION WARMER DRAPE

FDA Adverse Event
Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·June 22, 2016

BD CONNECTA¿ STOPCOCK

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·February 12, 2019

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code LWP·June 7, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 6, 2011

FOOT CHOICE THERAPEUTIC DEVICE

FDA Adverse Event
Injury ·YAS HEALTHY FITNESS CO. LTD.·Product code ISA·September 4, 2008

CONNECTA PLUS3 7 CM WHITE BLEND

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·February 26, 2019

WARMER DRAPE

FDA Adverse Event
Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·February 22, 2016

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020