12 results
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25ms
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Sources: EU EUDAMED, US FDA
GABBAY-FRATER SUTURE GUIDE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001972·VITROS Immunodiagnostic Products Anti-HBs Quant...
ACUMED
FDA UDI
Acumed LLC·10806378099960·Congruent Hexalobe Screw Caddy
ATRIUM LITE MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BULLSEYE BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR XL TAP SLV ADAP 12/14+2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 23, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013
CIDEX PLUS 28 DAY SOLUTION
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code LRJ·August 17, 2010
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·May 6, 2020
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024