673 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNIFIL FLOW
FDA 510(k)
FDA Class 2
·Dental
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65820203421·Channels Paper Points
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040100554·Channels Paper Points
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313756·IMPACTOR BIT Ø42mm
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103605·Midway Select Sutures 3-0 Chromic Gut C6 27" (12)
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
M2376A DEVICELINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 25, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 16, 2011
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·March 27, 2008
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 2, 2011
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
INFANT LOW FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 8, 2012
9611451-2007-00333
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 13, 2007
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·January 20, 2010
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·June 27, 2017
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·January 14, 2009
SINGLE-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 30, 2010
9611451-2007-00335
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 19, 2007
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026