11 results
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18ms
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Sources: EU EUDAMED, US FDA
LUMEND FRONTRUNNER CTO CORONARY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 20, 2026
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PHLEBOPUMP, MODEL 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
RX ACCULINK CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·July 12, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·March 20, 2013
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 8, 2011
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·March 14, 2008
SINGLE USE BIOPSY VALVE (STERILE)
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code EOQ·July 26, 2021
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