13 results
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20ms
·
Sources: EU EUDAMED, US FDA
HemosIL Factor V Leiden (APC Resistance V)
FDA 510(k)
FDA Class 2
·Hematology
Milling Blank
FDA UDI
BICON, LLC·00813110028617·10mm UA5 Milling Blank - 2.5mm Post
LEONE SPA
FDA UDI
LEONE SPA·08033707097754·ABUTMENT TI-BASE FOR EXACONNECT
Milling Blank
FDA UDI
BICON, LLC·00813110029324·10mm UA5 Milling Blank - 2.5mm Tall Post
BRIVANT GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
VALO Grand
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 22, 2011
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 1, 2013
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 26, 2024
MECTALIF TRANSFORAMINAL CAGES TIPEEK
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MAX·April 25, 2025
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021