21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA RETIC PLUS
FDA 510(k)
FDA Class 2
·Hematology
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0104010·Caddie Lid, Trials
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100610·Caddie Lid, Modular Bone Screws
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0104010·Caddie Lid, Cages, Universal
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
FDA 510(k)
FDA Class 2
·General Hospital
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025
INSET I
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 6, 2025
8010461-2005-00001
FDA Adverse Event
Other
·Product code LXH·May 13, 2005
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 10, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 10, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 10, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 10, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 10, 2025
COCR 01.25.011 COCR BALL HEAD 12/14 28 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·September 15, 2021
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007
LASSO¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·March 19, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 8, 2011
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