17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CYNOSURE SMARTLIPO MPX LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BILOX PROSTHESIS HEAD 12/14 28MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014
BIOLUCENT MAMMOGRAPHY CUSHION
FDA 510(k)
FDA Class 2
·Radiology
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014
BIOLOX PROSTHESIS HEAD 12/14 28MM M
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012
BIOLOX PROSTHESIS HEAD 12/14 32MM L
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010
BIOLOX PROSTHESIS HEAD 12/14 28MM S
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC·Product code HWT·July 25, 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