12 results · 21ms · Sources: EU EUDAMED, US FDA

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WIZARD 230 NASAL PILOW MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

LARGE CANNULATED SCREWS

FDA UDI
Smith & Nephew, Inc.·03596010063977·6.5MM UNIVERSAL CANNULATED SCREW 110MM

SYNTHES CRANIOFACIAL PLATES

FDA 510(k)
FDA Class 2 ·Dental

ONCO TRAC MODEL 1, 2, 4

FDA 510(k)
FDA Class 2 ·Radiology

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

VICTORY XL DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 21, 2013

UNKNOWN DEPUY LCS PATELLA

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 2, 2011

XIA TITANIUM 4.5 BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

Artis Q biplane, Model Number 10848282

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

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