11 results
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26ms
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Sources: EU EUDAMED, US FDA
DRUALIFT 500
FDA 510(k)
FDA Class 2
·General Hospital
Preat
FDA UDI
Preat Corporation·00842092133378·Sphero Block Abutment Biohorizon 3.0 x 7mm (1.8...
ACUMED
FDA UDI
Acumed LLC·10806378052538·Polarus® 3 Tray Base 2/2
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136551·
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
FDA 510(k)
FDA Class 2
·Immunology
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
FDA 510(k)
FDA Class 2
·Cardiovascular
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014
ENDURANT STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 23, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 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
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