10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CADWELL EASYNET NASAL PRESSURE MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
Azur
FDA UDI
PURELIFE, LLC·D79010617051·Azur Nitrile Powder-Free, X-Large, Ultra-soft n...
SUPREMCAST
FDA 510(k)
FDA Class 2
·Dental
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
FDA 510(k)
FDA Class 2
·Neurology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 29, 2013
CANNULA AND OBTURATOR
FDA Adverse Event
SMITH & NEPHEW, INC.·Product code NBH·June 10, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir.
FDA Recall
Terminated
·Hospira Inc.·Product code DQO·November 2, 2004
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015