13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
FDA 510(k)
FDA Class 1
·Microbiology
ArgenZ HT+ 95x16 A4
FDA UDI
ARGEN CORPORATION, THE·D818122718·Dental porcelain/ceramic restoration kit
OTHER EXFIX
FDA UDI
Smith & Nephew, Inc.·03596010069528·TITANIUM HALF PIN 5.0MM X 75MM
Portex
FDA UDI
ICU MEDICAL, INC.·00351688027170·
DIGITAL THERMOMETER; DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Gibralt
FDA UDI
Choice Spine, LP·00840996169509·GIBRALT,DRILL,FIXED,2.7X18
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
SPECTRANETICS LEAD LOCKING DEVICE
FDA Adverse Event
Injury
·SPECTRANETICS CORPORATION·Product code DRB·May 21, 2013
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code INM·September 26, 2014
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTL LTD.·Product code KWA·June 3, 2011
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012