12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
Up&Up
FDA UDI
TARGET CORPORATION·00014007456661·Pink Pre-Cut Kinesiology Tape - 2in x 10in - Up&Up
LINEAR 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2022
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDQ·April 22, 2013
LIGASURE IMPACT THORACIC
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 14, 2011
FLASH PAK
FDA Adverse Event
Malfunction
·SYMMETRY MEDICAL·Product code KCT·June 30, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018