11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ArgenZ Esthetic Plus
FDA 510(k)
FDA Class 2
·Dental
Oticon
FDA UDI
Oticon A/S·05707131283610·RIA2, BTE 13 WL 100 TC
Leg Bag
FDA UDI
C. R. Bard, Inc.·00801741050893·Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Va...
PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
FDA 510(k)
FDA Class 2
·Radiology
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
FDA 510(k)
FDA Class 2
·Cardiovascular
VUE PACS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014
UNKNOWN DEPUY POLY SPACER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSD·June 29, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 3, 2008
ES2 CANNULATED MODULAR TAP
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code LXH·January 23, 2017
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015