21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Actis DuoFix Hip Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
TALOS®-C
FDA UDI
SpineArt SA·07640375236456·STERILE TALOS®-C (HA) PEEK PLANAR IBFD
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521609070·
Vusion CS Plus
FDA UDI
Ortho Development Corporation·00822409025565·16 mm x 9 mm x 7 Degree Lordotic
KARL STORZ VIDEO GASTROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
FDA 510(k)
FDA Class 1
·General Hospital
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·November 18, 2021
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·September 3, 2021
ZOLL IVTM THERMOGARD XP
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION·Product code NCX·September 3, 2021
LINEAR 3-6
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 13, 2023
CLEARLINK PACLITAXEL SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024
MPACT FLAT PE HC LINER Ø 36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 25, 2016
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 13, 2011
DOW CORNING BREAST IMPLANTS
FDA Adverse Event
Injury
·DOW CORNING·Product code FTR·September 16, 2008
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
CLEARLINK SOLUTION ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 2, 2025
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 15, 2016
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026