11 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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CCD CAMERA, MODEL PKP-06000-000
FDA 510(k)
FDA Class 2
·Radiology
INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH 24% VENTURI VALVE, BLUE
FDA UDI
Intersurgical Incorporated·05030267128044·INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH ...
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657016292·Laser Cysto Set w/Endoscope 23Fr Contin.Flow Sh...
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00840967162454·NARROW BLADE OFFSET THORACIC SUPRALAMINAR HOOK,...
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
FDA 510(k)
FDA Class 2
·Orthopedic
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
FDA 510(k)
FDA Class 2
·General Hospital
MITEK HEALIX ADVANCE BR 5.5 MM - 3 SUTURE W/ORTHCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·March 27, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·March 11, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008
60 IN ULTRA MINIBORE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·June 24, 2020
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