13 results
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20ms
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Sources: EU EUDAMED, US FDA
TORFLEX TRANSSEPTAL GUIDING SHEATH
FDA 510(k)
FDA Class 1
·Immunology
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033541647·
Cosmolock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 14, 2026
Clever Choice Comfort EZ
FDA UDI
SIMPLE DIAGNOSTICS INC·00898302139197·Insulin Syringe 31G 1cc 5/16"
DATACAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MALE NATURAL RUBBER LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIDECO LILIPUT ECMO M PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 20, 2012
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
FDA Adverse Event
Death
·MPRI·Product code NVY·March 21, 2013
OPTISENSE
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
CONMED BSC/SAG SAW BLADES
FDA Adverse Event
Other
·CON MED·Product code HWE·March 13, 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
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015