35 results · 30ms · Sources: EU EUDAMED, US FDA

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Neocis Guidance System (NGS) with Yomi Plan v2.0.1

FDA 510(k)
FDA Class 2 ·Dental

TWINFIX

FDA UDI
Smith & Nephew, Inc.·03596010539311·TWINFIX AB 5.0 MM SUTURE ANCHOR, ...

LUPINE ORTHOCORD

FDA UDI
Medos International Sàrl·10886705001095·LUPINE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbabl...

Zavation

FDA UDI
Zavation LLC·00842166132399·Ti3Z CIF 13mmx15mmx11mm -7 deg

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319707425·Freeman Rake Retractor 4" (10cm), 4 sharp prong...

ZAVATION

FDA UDI
Zavation LLC·00842166104488·CIF 13x15, 7 deg, -11

ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NON-CONTACT THERMOMETER

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

CAPTIVATOR OVAL SNARE STANDARD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code FDI·October 23, 2008

EON RECHARGEABLE IPG, 16-CHANNEL

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 28, 2011

QUADRA ASSURA CRT-D, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711

FDA Recall
Open, Classified ·Smith & Nephew, Inc.·Product code MAI·September 9, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 18, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

PENTAX

FDA Adverse Event
Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021