21 results · 27ms · Sources: EU EUDAMED, US FDA

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ASTRA SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768512·GENUMEDI PSS GREEN VII

OSS™ Orthopedic Salvage System

FDA UDI
Biomet Orthopedics, LLC·00880304239401·

AGXO

FDA UDI
Oticon A/S·05707131288608·H110V2, DESIGNRITE 10 WL TC AGXO

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·10842962102265·RAPIDCUT BLADE, SMALL JOINT, 2.9MM, S

ELITE IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

XKNIFE 5

FDA 510(k)
FDA Class 2 ·Radiology

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962102268·ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 3.3mm x...

X-SUIT NIR COVERED BILIARY METALLIC STENT

FDA Adverse Event
Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

EAGLE SCREW, 16MM

FDA Adverse Event
Injury ·DEPUY SPINE, INC.·Product code KWQ·September 5, 2008

PROLIEVE TEMPERATURE MONITOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 21, 2008

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

FAST-FIX 360 CURVED NDL DELIVERY SYS

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code GAT·February 10, 2026

KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

RADIFOCUS GLIDEWIRE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

TERUMO RADIFOCUS GUIDE WIRE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

GLIDEWIRE GT

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016