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

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VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL

FDA 510(k)
FDA Class 2 ·General Hospital

Starbond Easy

FDA UDI
S & S Scheftner GmbH·04260207854233·Disc, 15 mm ø 98,3 mm / with edging

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319704851·Lorna (Edna) Towel Clamp 5-1/4" (13.3cm), non-p...

TEMPUS CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UCP DRUG SCREENING TEST CUPS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 24, 2023

ENDOSKELETON® TO 4 DEG LORDOTIC, IMPLANT, 22X10MM, PLIF

FDA Adverse Event
Malfunction ·TITAN SPINE, LLC·Product code MAX·July 19, 2016

ALTRUA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·May 31, 2013

ENTERALITE INFINITY ENTERAL PUMP

FDA Adverse Event
Other ·ZYVEK·Product code LZH·June 21, 2011

VENTED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 16, 2015

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.

FDA Enforcement
Class I ·Terminated·Teleflex Medical·July 1, 2015