14 results · 28ms · 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.

GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

A.S.A.P.® All Surface Access Polishers 6-Pack Refill (Small)

FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003074·Dental polishing point

A.S.A.P.® All Surface Access Polishers 6-Pack Refill (Small)

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012904·Dental polishing point

LYNX

FDA UDI
HNM TOTAL RECON LLC·00841742112879·LYNX Distal Tibial Antero Lat Locking Plate, Ti...

IQVITALS AND IQVITALS SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

NANMA VACUUM PUMP

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

FDA Adverse Event
Malfunction ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 14, 2021

PEN NDL 31GA 5MM 100BX 1200 USA

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 23, 2021

BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 8, 2019

PRECISION®

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2013

CONCERTO CRT-D DR AT

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code NIK·June 16, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·August 21, 2008

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015

TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

FDA Enforcement
Class II ·Terminated·Tenex Health Inc·May 14, 2014