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

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US SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

RN Octagonimpression cap, screwed built-in handle

FDA UDI
BIO CONCEPT Co., Ltd.·06947600302155·

OMNIBotics

FDA UDI
Omni Life Science, Inc.·00841690195368·3.5mm Hex Driver

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L062030120·6mm H x 20mm W x 30mm L XLIF Trial 12 degree Lo...

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0620000·Universal Removal Set

PORTABLE INTENSIVE CARE UNIT

FDA 510(k)
FDA Class 3 ·Cardiovascular

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 15, 2026

DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

BD SYRINGE 20ML LL 120/PKG

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026

BD SYRINGE 20ML LL 120/PKG

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026

M.U.S.T. PEDICLE SCREW SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·September 18, 2025

LANCET-100

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code QRK·April 3, 2026

BD PLASTIPAK LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026

BD PLASTIPAK LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 23, 2026

MOTIFESH SOFT TISSUE PATCH (OMYRA IN EUROPE)

FDA Adverse Event
Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·May 27, 2014

OMYRA MESH (BRANDED AS MOTIFMESH IN THE US)

FDA Adverse Event
Other ·PROXY BIOMEDICAL LTD.·Product code FTL·November 20, 2012

ENDURANT II

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 16, 2013

2600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011

LEVEEN COACCESS NEEDLE ELECTRODE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JOS·June 13, 2008