13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Synthes GmbH·10886982151773·3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RE...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112724·BARRON VACUUM PUNCH 6.75MM
Sapphire II Pro
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942075·Balloon Dilatation Catheter
CBSU MICROKERATOME
FDA Adverse Event
Injury
·MORIA SA·Product code HMY·March 17, 2025
BANDVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLAMEND
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTM·October 24, 2008
TRIDENT 0 DEG INSERT 40MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·July 8, 2011
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 8, 2013
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·July 11, 2018
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025