22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
TRIDENT 0 DEG INSERT 44MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MRA·August 31, 2011
CURLIN IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·March 18, 2013
THORACOPORT 11.5MM TROCAR
FDA Adverse Event
Injury
·USSC PUERTO RICO, INC.·Product code GCJ·April 8, 2011
ARTERIAL CANNULA
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DWF·June 18, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 25, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NKB·October 8, 2010
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014