23 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEKA SMARTXIDE AND DELIVERY ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003044·77 V2 ASSY PETITE 22ID W/HG
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045135·Paddle Shaver, 12mm
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180512487·ALIF Box Cutter, 4 MM
MODIFICATION TO: ECAT LSO PET/CT SCANNER
FDA 510(k)
FDA Class 2
·Radiology
GETINGE 400HC/500HC SERIES STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 15, 2024
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·May 8, 2026
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·April 3, 2026
PINN CAN BONE SCREW 6.5MMX20MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 15, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 24, 2011
F1500 MON F NEW
FDA Adverse Event
Death
·TYCO HEALTHCARE/KENDALL·Product code FLL·August 13, 2008
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·November 26, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·August 20, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·July 22, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·February 4, 2026
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·January 23, 2026