23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoLink Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237902400·1.25" Round, Foam
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850958007756·1.25" Round, Foam
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850958007753·1.25" Round, Foam, Case of 10
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
FDA 510(k)
FDA Class 2
·Cardiovascular
AURORA DS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·July 30, 2002
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 7, 2015
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 7, 2015
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 7, 2015
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 7, 2015
WALLFLEX DUODENAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2011
+4 ENDURON LINER 28ID X 54OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·July 2, 2013
INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LKK·May 2, 2012
WALLFLEX COLONIC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 18, 2024
WALLFLEX COLONIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024
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