22 results
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36ms
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Sources: EU EUDAMED, US FDA
WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601624·SOD CANN 8MM 60MM WORKING LG
HOTWIRE™ RF GUIDEWIRE
FDA UDI
Atraverse Medical, Inc·00850057445145·The HOTWIRE™ is a sterile, single-use guidewire...
Surgimedics®
FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020623·Smoke Evacuation Tubing
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109256·DB BKT MINI MS UL CEN 018 T+17 A+4 R=0
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482128619·Ultra Instruments Forceps; Claw Extractor; Heav...
Marker Double Ended 3.5mm-4mm
FDA UDI
BLINK MEDICAL LIMITED·05060480407978·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515226500·Buck Ear Curette, 1.5mm, sz 0, str, sharp
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776081546·Claw Forcep
ELECSYS THYROGLOBULIN CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GUIDE CATHETERS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
ELLIPSE DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE·Product code OUR·January 3, 2013
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·October 18, 2010
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code OWF·August 2, 2018
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
FDA Recall
Terminated
·3M Company Health Care Business 3m Center·Product code NOC·November 1, 2017
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·February 14, 2018
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025