13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
FDA 510(k)
FDA Class 2
·Physical Medicine
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033140·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319701423·Finger Ring Cutter 6-1/2" (16.3cm), with circul...
INFINITI® Warfarin Amplification Mix
FDA UDI
AUTOGENOMICS, INC·00850009370181·CYP450 2C9 drug metabolizing enzyme and VKORC1 ...
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
FDA 510(k)
FDA Class 2
·Anesthesiology
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·July 13, 2016
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 1, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 28, 2011
PRECISION XTRA / OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 22, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024