11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reactor(TM) Trocar and Sleeve
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171029359·PESSARY, RING #5, W/KNOB AND W/SUPPORT, 3"
ENSITE VELOCITY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
FDA 510(k)
FDA Class 2
·Radiology
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
IPUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 6, 2013
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
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