13 results
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19ms
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Sources: EU EUDAMED, US FDA
CTBOX CERVICAL/LUMBAR TRACTION
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
Richard Wolf GmbH·04055207013953·FIBER LIGHT CABLE Ø 3.5MM TL 2.3M
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496063353·SOCKS FOR YOU BAMBOO SQUARE, SIZE L, NERO, GRAD...
NEUROSPECTQUAD GAMMA CAMERA
FDA 510(k)
FDA Class 2
·Radiology
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
FDA 510(k)
FDA Class 1
·General Hospital
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 27, 2013
STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·April 11, 2011
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·June 19, 2008
MOZAIK
FDA Adverse Event
Injury
·ISOTIS ORTHOBIOLOGICS INC.·Product code MQV·January 7, 2021
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·June 20, 2012
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