10 results
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35ms
·
Sources: EU EUDAMED, US FDA
SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
Ti Screw ES
FDA UDI
Biomet Orthopedics, LLC·00880304404403·
DELTRAN
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H6719025870·DELTRAN II, Disposable Pressure Transducer Syst...
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
BRILLIANCE 64
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·May 9, 2014
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 8, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·November 12, 2010
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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