13 results · 19ms · Sources: EU EUDAMED, US FDA

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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