27 results · 31ms · Sources: EU EUDAMED, US FDA

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BioCode Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)
FDA Class 2 ·Microbiology

X-CORE

FDA UDI
Nuvasive, Inc.·00887517426529·X-CORE 2 Ti Core, Ø18x28-41mm

Finn® Knee System

FDA UDI
Biomet Orthopedics, LLC·00887868251757·

FINN KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304268869·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694004879·150 x 300mm Mesh Plate

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668100943·JAFFE LID RETRACTOR SMALL

8.0MHZ PENCIL PROBE 10'

FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787020861·

ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SHEATHES STERILE ULTRASOUND GEL

FDA 510(k)
FDA Class 2 ·Radiology

Distraction Paddle - 9mm

FDA UDI
CAPTIVA SPINE, INC.·00850065741642·Distraction Paddle - 9mm

RD SET YI

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

RD SET DCI

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023

TI MATRIXMANDIBLE SUBCONDYLAR PLATE LAMBDA/LEFT/1.0MM THICK

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JEY·October 17, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011

SROM*EXTENSN,TIB STEM,17X100MM

FDA Adverse Event
Malfunction ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 20, 2013

TREK¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

RD SET

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022

ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 3, 2021