13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018639·Metzenbaum Scissors Curved
Prodigy Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
28MM I.D. 42MM O.D. SIZE E BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·March 31, 2026
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145539·R UHMWPE PS PLUS Tibial Insert Sz A 14mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147670·PS Plus Tibia Insert Trial Size A, 14mm - Right
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523144228·R CIMA HXL PS PLUS Tibial Insert Sz A 14mm
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523143450·R E-CIMA Vitamin E PS PLUS Tibial Insert Sz A 14mm
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 6, 2011
OTHER
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
FDA Enforcement
Class II
·Ongoing·Diasorin Inc.·December 18, 2024