68 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
FDA 510(k)
FDA Class 2
·Neurology
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
Redicare
FDA UDI
REDICARE LLC·B70901020180·Resuscitation Kit in a plastic container contai...
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828115414·GEN4 INTERACTIVE
RHEAD
FDA UDI
Stryker GmbH·00886385024998·Recon Stem Implant Plasma Coated, Size 1
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828115315·GEN4 INTERACTIVE
ALL SILICONE FOLEY BALLOON CATHETER
FDA UDI
Sewoon Medical Co., Ltd.·08806369402545·2way/Translucent 30cc 18fr
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981309527·Adjustable Locking Screwdriver, Short
Symmetry Crile-Wood
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482054529·Symmetry® Needle Holder, Crile-Wood, 7 in, 177 mm
HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·January 4, 2018
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026028·PLATEAU Interbody, Straight, Bulleted, 10mm 20m...
NDO SURGICAL SURGICAL OVERTUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·August 29, 2017
UNKNOWN STRATA VALVE/SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·April 23, 2018
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 22, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 18, 2011
ANALYTICAL MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 7, 2008
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Enforcement
Class II
·Ongoing·Karl Storz Endoscopy·May 18, 2022
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code EOB·April 1, 2022