19 results · 23ms · Sources: EU EUDAMED, US FDA

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EverLift Submucosal Lifting Agent

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113363·CLEAR CORNEA KNIFE 3.0MM (BX/5)

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)

ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201

FDA 510(k)
FDA Class 2 ·Cardiovascular

S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ ACCUSEAL TAP

FDA Adverse Event
Malfunction ·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EXH·September 17, 2014

ORTHO SUMMIT SAMPLE HANDLING SYSTEM

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code MMH·August 11, 2011

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 2, 2013

EXCOR®

FDA Adverse Event
Injury ·BERLIN HEART GMBH·Product code DSQ·October 19, 2023

UNKNOWN COOL TIP ELECRTRODE

FDA Adverse Event
Death ·COVIDIEN MFG DC BOULDER·Product code GEI·December 11, 2024

MEDTRONIC LEAD

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DXY·August 20, 2024

P9 IMPELLA SWAN CL

FDA Adverse Event
Death ·ABIOMED, INC.·Product code OZD·July 21, 2025

MEDTRONIC ICD

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code DXY·August 21, 2024

UNKNOWN COOL TIP ELECRTRODE

FDA Adverse Event
Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·December 10, 2024

SENSOR UROLOGICAL GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EZB·June 18, 2025

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·March 1, 2024

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 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