9 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981085·anteriors; shade A3.5; mould CS2
LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINIMED SOF-SET ULTIMATE MMT 315
FDA Adverse Event
Malfunction
·MINIMED TECHNOLOGIES, INC.·Product code FMI·October 14, 1998
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FRN·February 20, 2013
LIFTING POLE & HANDLE ASSAY
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH·Product code FNL·January 28, 2011
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·August 5, 2014
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026