13 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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