14 results
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26ms
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Sources: EU EUDAMED, US FDA
MAINFLOW BACTERIA FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551202012·Retractor, 30 x 16 mm, 22 cm
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135264·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776110031·Micro Vascular Scissor
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022388·FastTrack Effort Interface Kit, Grael
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCELERATOR RECIPROCATING CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 8, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 23, 2012
NEXGEN PROLONG ALL-POLY PATELLA
FDA Adverse Event
Malfunction
·ZIMMER·Product code JWH·May 26, 2015
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·September 30, 2015
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
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012