21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
FDA 510(k)
FDA Class 2
·Anesthesiology
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517772·
CORINNE MCCORMACK INC.
FDA UDI
FGX INTERNATIONAL INC.·00887661754561·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517796·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517802·
CORINNE MCCORMACK INC.
FDA UDI
FGX INTERNATIONAL INC.·00887661754530·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517765·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517789·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033517819·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361013099·PedFuse Remind LES, Quad-H, 7.0mm x 65mm
CORINNE MCCORMACK INC.
FDA UDI
FGX INTERNATIONAL INC.·00887661754578·
COBAS INTEGRA AMPHETAMINES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
FDA 510(k)
FDA Class 2
·General Hospital
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 21, 2025
INSET GUARD
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 28, 2026
MYNXGRIP VASCULAR CLOSURE DEVICE 5F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·March 20, 2013
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
MBT CEM KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·March 14, 2008
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022