16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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