12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Asnis
FDA UDI
Stryker GmbH·07613154578191·CANNULATED SCREW
SCFE Screw
FDA UDI
ORTHOPEDIATRICS CORP.·00841132114551·4.0mm X 28mm SHORT THREAD CANNULATED SCREW
ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
FDA 510(k)
FDA Class 3
·Cardiovascular
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013
TWIST DRILL
FDA Adverse Event
Injury
·KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG·Product code HTW·March 27, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 7, 2011
RSVR MMT-332A 10PK PRDGM 3CC 14L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·April 14, 2008
OMNI III TEE Transducer Probe
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·September 3, 2025
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018