18 results · 31ms · Sources: EU EUDAMED, US FDA

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BD Intraosseous Infusion System

FDA 510(k)
FDA Class 2 ·General Hospital

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113974·HYDRO-DISSECT CANNULA 25GA ANGLED 8MM

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113936·GIANNETTI "BIG SPURT" CANNULA 21GA

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113783·AIR INJECT CANNULA 25GA

DUPLOGRIP

FDA 510(k)
FDA Class 2 ·General Hospital

CANDELA GENTLE YAG LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·November 18, 2002

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 9, 2022

RESOLUTION CLIP DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·October 17, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

CMF CUSTOMIZED IMPLANT KIT X-LARGE

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KKY·July 2, 2013

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 20, 2021

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·October 19, 2022

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025