15 results · 21ms · 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.

STAXX(R) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Oticon

FDA UDI
Oticon A/S·05707131260529·RIA PRO, RITE 312 WL TC

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613025014·Metzenbaum Nelson Scissors, Super Cut, Curved, ...

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1671332070·

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

CLYDESDALE PTC SPINAL SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

SONO TAP, TUOHY SONO

FDA 510(k)
FDA Class 2 ·Anesthesiology

JBAIDS Q FEVER DETECTION KIT

FDA 510(k)
FDA Class 1 ·Microbiology

PROLITE MESH

FDA Adverse Event
Injury ·ATRIUM MEDICAL CORP.·Product code FTL·May 24, 2013

L9000 LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·May 9, 2011

PATIENT RETURN GROUNDING PAD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ODR·August 22, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

FDA Enforcement
Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

Achieva 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015