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