15 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FRAXEL III SR LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136391·Ti-6Al-4V ALIF Implant 38 X 30, 15mm Height 16°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136407·Ti-6Al-4V ALIF Implant 38 X 30, 17mm Height 16°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136384·Ti-6Al-4V ALIF Implant 38 X 30, 13mm Height 16°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136414·Ti-6Al-4V ALIF Implant 38 X 30, 19mm Height 16°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136421·Ti-6Al-4V ALIF Implant 38 X 30, 21mm Height 16°...
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
FDA 510(k)
FDA Class 2
·Neurology
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018
RSP SHOULDER
FDA Adverse Event
ENCORE MEDICAL, L.P.·Product code KWS·April 17, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 21, 2011
PRECISION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 19, 2008
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018
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