16 results
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18ms
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Sources: EU EUDAMED, US FDA
URINARY CATHETER SAMPLING KIT
FDA 510(k)
FDA Class 1
·Pathology
Polishers
FDA UDI
DFS - DIAMON GmbH·04057176147271·UPORAL C cup CA, pu: 6 pcs
Reprocessed Acutrak 2 Long Drill Bit, 3.3mm, Cannulated
FDA UDI
SURETEK MEDICAL·B3908009461·
Acumed
FDA UDI
Provision·B504OMK8009460·
ACUMED
FDA UDI
Acumed LLC·10806378045554·Acutrak 2® - 4.7 Long Drill
INTRAVSCULAR ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RECIPROC BLUE FILES, 6X, STERILE
FDA Adverse Event
Malfunction
·VDW GMBH·Product code EKS·June 2, 2023
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 8, 2014
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 18, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 7, 2007
Braun wheelchair lift, model NL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicles.
FDA Recall
Terminated
·The Braun Corporation·Product code ING·August 15, 2007
Braun wheelchair lift, model NVL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicles.
FDA Recall
Terminated
·The Braun Corporation·Product code ING·August 15, 2007
Braun wheelchair lift, model NCL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicles.
FDA Recall
Terminated
·The Braun Corporation·Product code ING·August 15, 2007
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
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023