16 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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truFreeze System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131283627·RIA2, BTE 13 WL 100 DBL
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095658867·Filter pipette tips, 200uL, low retention, 96/r...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P1509200·15mm PLIF Implant 9mm Wide 20mm Length
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100097·BARRAQUER SPECULUM SOLID SMALL
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P15092070·15mm PLIF Implant 9mm Wide 20mm Length 7 Degrees
Healing Abutment
FDA UDI
BICON, LLC·00813110021175·5.0 x 4.0mm Healing Abutment - 2.0mm Post
PULSAVAC®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024375246·Component Kit (Low Pressure)
MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
CZR PRESS LF STAINS
FDA 510(k)
FDA Class 2
·Dental
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 28, 2019
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014
S-ROM CUP ACE, A2 L32, 66DP+6
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 29, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
FDA Adverse Event
Malfunction
·CHARTER MEDICAL, LTD.·Product code LPZ·March 8, 2018
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