13 results · 18ms · Sources: EU EUDAMED, US FDA

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SURGIFLATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123106·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 100mm

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123267·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 100mm

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122925·K-WIRE - DOUBLE TROCAR 1.2mm DIA x 150mm

TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT

FDA 510(k)
FDA Class 2 ·Physical Medicine

TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

FDA 510(k)
FDA Class 2 ·Neurology

COMPLETE RADIOLUCENT INSERTION HANDLE

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·March 15, 2021

BI-METRIC HIP LATERALISED FEMORAL STEM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 17, 2013

CAPSURE SP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 6, 2014

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025