35 results
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30ms
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Sources: EU EUDAMED, US FDA
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