11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KUMAR T-ANCHORS HERNIA SET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Speedlock
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657064606·Biopsy Spoon, 5mm, Double Action Handle: 1366 ...
Speedlock
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657062244·Needle Holder, Pointed, 5mm, 10mm Jaw Length H...
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
FDA 510(k)
FDA Class 2
·Radiology
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENERGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 26, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 22, 2011
PULSE GEN MODEL 101
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·July 24, 2008
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015