10 results · 25ms · Sources: EU EUDAMED, US FDA

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DORMIE NECK SUPPORT SYSTEM

FDA 510(k)
FDA Class 1 ·Physical Medicine

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515239555·Freer Septum Knife, E model, 6 3/8"

V-STICK VASCULAR ACCESS SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

OT VERIO PRO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 16, 2010

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2014

Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554

FDA Enforcement
Class II ·Ongoing·Biomet, Inc.·November 29, 2023

Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014