12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981286·anteriors; shade C2; mould IL2
Symmetry Paddle
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482153901·Symmetry® Forceps, Paddle Babcock, Ratcheting H...
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
FDA 510(k)
FDA Class 2
·Hematology
Ambu aScope RLS Slim
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·February 8, 2011
BATTERY HANDPIECE, MODULAR, FOR TRAUMA RECON SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·August 5, 2014
PIPELINE FLEX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 12, 2021
PIPELINE FLEX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 12, 2021
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·June 3, 2009
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025