16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Grasping Forceps FG-52D/FG-54D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776183349·Lambotte Osteotome cvd
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776183356·LAMBOTTE OSTEOTOME CURVED
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780384113·Integra® Jarit® Lambotte Osteotome, 9", Curved,...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250263200·ceraMotion® Zr Touch Up Gingival G2, 20 g / den...
K-Pack II Needle-21G x 2
FDA 510(k)
FDA Class 2
·General Hospital
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
FDA 510(k)
FDA Class 2
·General Hospital
FREESTYLE
FDA Adverse Event
Injury
·THERASENSE, INC.·Product code LFR·March 17, 2005
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·April 27, 2026
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 7, 2016
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 15, 2011
OMNIPULSE (TM)
FDA Adverse Event
Malfunction
·TRIMEDYNE, INC.·Product code GEX·December 4, 2008
EDM LUMBAR DRAINAGE KIT, OPEN TIP
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·July 26, 2013
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 14, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013