20 results · 32ms · Sources: EU EUDAMED, US FDA

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HANAROSTENT Trachea/Bronchium (CCC)

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

CoRoent

FDA UDI
Nuvasive, Inc.·00887517628343·CoRoent Ant TLIF Ti, 10x11x34mm 12°

24PW - Hanta Virus

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White

FAA Airline - 24 Poly White

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013244·FAA Airline - 24 Poly White

24M - Tampa Electric Co.

FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.

NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

FDA 510(k)
FDA Class 2 ·Dental

P.O.P. PAIN KIT

FDA 510(k)
FDA Class 2 ·General Hospital

AVENIR CMPL HA STD NC SIZE 6

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·February 11, 2026

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

BD VACUTAINER® ONE USE HOLDER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·July 11, 2024

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014

HEARTSTREAM FR2

FDA Adverse Event
Malfunction ·PHILPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2013

CONSULTA CRT-D

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

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·May 15, 2022

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 17, 2022

CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021