23 results · 30ms · Sources: EU EUDAMED, 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