18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UST-5550-R; UST-5536-R; L43K
FDA 510(k)
FDA Class 2
·Radiology
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295057307·FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZ...
GENUINE FIRST AID CPR MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2015
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWP·June 7, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 23, 2022
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
FUSION COMPACT
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code PGW·July 14, 2023
BD CONNECTA¿
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·April 12, 2023
Bioplate Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant.
FDA Recall
Terminated
·Bioplate Inc·Product code JEY·March 31, 2010
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014