11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C.O.L.D.A.
FDA 510(k)
FDA Class 1
·Ophthalmic
Sklar
FDA UDI
SKLAR CORPORATION·50649111456396·MOORFIELD SUT FCP MICR CS/10
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108352·BARRAQUER NEEDLE HOLDER CURVED
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
ATRICURE ABLATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MULTI SPECT 2 [510(K) K913630]
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 19, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·February 15, 2013
EPSILON DURASUL STANDARD INSERT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JDI·December 21, 2010
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