21 results · 27ms · Sources: EU EUDAMED, US FDA

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OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)

FDA 510(k)
FDA Class 2 ·Anesthesiology

CUSTOM PROCEDURE KIT

FDA UDI
MEDIVATORS INC.·40677964010192·Endo Carry-On Procedure Kit

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001121·artVeneer life lower anteriors, UCS, A35

Silicone Tubing

FDA UDI
INVOTEC INTERNATIONAL, INC.·00818501022724·Silicone Tubing

NA

FDA UDI
Berchtold Holding GmbH·07613327170191·Elongation bar for anesthesia screen. Keep Dry.

BD PHASEAL PROTECTOR P50

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·June 29, 2020

TITAN XL

FDA Adverse Event
Injury ·CUTERA·Product code GEX·June 14, 2010

LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902

FDA 510(k)
FDA Class 2 ·Cardiovascular

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)
FDA Class 2 ·Immunology

INTACS PRESCRIPTION INSERTS

FDA Adverse Event
Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

iBOT PMD with software version 01.05.24. Personal Mobility Device.

FDA Enforcement
Class II ·Ongoing·Mobius Mobility LLC·June 18, 2025

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

DESARA

FDA Adverse Event
Other ·CALDERA MEDICAL·Product code FTL·February 17, 2011

TUBE, GASTROINTESTINAL (AND ACCESS)

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (BASD)·Product code KNT·February 15, 2008

BD PHASEAL INJECTOR LUER LOCK N35C

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·June 29, 2020

INTACS PRESCRIPTION INSERTS

FDA Adverse Event
Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

PDS CORD UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code NEW·December 12, 2017

INTACS CORNEAL IMPLANTS

FDA Adverse Event
Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

INTACS PRESCRIPTION INSERTS

FDA Adverse Event
Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025