16 results · 18ms · Sources: EU EUDAMED, US FDA

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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