12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702546187·Elvarex Forte 3/Thigh High/Closed Toe, E-Versio...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702248029·ELVAREX 2/THIGH HIGH/SLANT-OPEN TOE-ELEPHANTIAS...
KAVO POLYLUX II
FDA 510(k)
FDA Class 2
·Dental
REBSTOCK YASARGIL ANEURYSM CLIP
FDA 510(k)
FDA Class 2
·Neurology
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 10, 2011
HYDROVIEW INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·July 28, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014