19 results · 24ms · Sources: EU EUDAMED, US FDA

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PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES

FDA 510(k)
FDA Class 3 ·Orthopedic

INJECTION AIDE UNIT FOR DIAGETICS

FDA 510(k)
FDA Class 2 ·General Hospital

LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS

FDA 510(k)
FDA Class 2 ·Anesthesiology

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·May 5, 2021

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·January 21, 2020

NATURALYTE

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014

LANX SPINAL FIXATION SYSTEM

FDA Adverse Event
Malfunction ·LANX, INC.·Product code MNI·November 23, 2010

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 28, 2013

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 17, 2023

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 20, 2023

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 23, 2024

COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·May 5, 2017

COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWS·May 5, 2017

COMPREHENSIVE REVERSE SHOULDER E1 HUMERAL BEARING

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code PAO·May 5, 2017

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·June 3, 2021

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 15, 2024

CHAMBER COMPLETE AUTOFEED 900

FDA Adverse Event
Malfunction ·Product code BTT·February 4, 2021

Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

FDA Enforcement
Class I ·Terminated·Covidien·February 11, 2015

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