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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317320681·

PALOMAR SLP 1000

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EXSALT WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

CONTOUR NEXT

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014

CONTOUR NEXT

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013

THREE PEG PATELLA 35MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 17, 2025

40MM/4MM ANCHORING PIN

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·May 14, 2013

RESERVOIR 3ML MMT-332A

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 23, 2014

SERVO-S

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·May 26, 2011

INTUITRAK

FDA Adverse Event
Injury ·ENDOLOGIX·Product code MIH·October 28, 2015

TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

FDA Enforcement
Class II ·Terminated·Accuray Incorporated·January 3, 2018

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024