17 results · 24ms · Sources: EU EUDAMED, US FDA

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Pinnacle Radiation Therapy Planning System

FDA 510(k)
FDA Class 2 ·Radiology

OsteoMed

FDA UDI
OSTEOMED LLC·00845694014786·SpectrumTM LeFort III, Medium Activation Rod

SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

IFS PROFILE PLATES, SCREWS, AND WASHERS

FDA 510(k)
FDA Class 2 ·Orthopedic

EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)·Product code LWR·September 11, 2017

PERCOR STAT DL 9.5 FR. 34 CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 3, 1997

MINILINK TRANSMITTER

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·October 14, 2014

RENAISSANCE 29 P-WASHOBS10/04

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 14, 2013

PERCDLE DEVICE CONVENIENCE PACK

FDA Adverse Event
Other ·ARTHROCARE CORP.·Product code GEI·June 17, 2011

ALPHA I INFLATABLE PENILE PROSTHESIS

FDA Adverse Event
Injury ·MENTOR UROLOGY, INC.·Product code FHW·September 26, 1997

SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

RELION PEN NEEDLES 4MM X 32 GAUGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022

QUADRA H FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 20, 2024

ACE LINR-NEUT-40X58/60 RESTORIS XLVE

FDA Adverse Event
Injury ·MAKO SURGICAL CORP.·Product code OQG·November 24, 2015

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012