11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEPARIN COATED THERMODILUTION CATH & ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
Tronex International, Inc.
FDA UDI
TRONEX INTERNATIONAL, INC.·10097604911716·Glove, Exam, Nitrile, Chemotherapy Rated, Finge...
FULL AUTO TONOMETER MODEL TX-20
FDA 510(k)
FDA Class 2
·Ophthalmic
OXOID PBP2 1 LATEX AGGLUTINATION TEST
FDA 510(k)
FDA Class 2
·Microbiology
PATCH
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code NHW·January 11, 2013
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·November 16, 2010
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021