19 results · 41ms · Sources: EU EUDAMED, US FDA

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BETA-TCP GRANULES

FDA 510(k)
FDA Class 2 ·Orthopedic

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564030559·HIP A

5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

FDA Adverse Event
Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·January 26, 2015

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·March 2, 2015

IMPLANT, FIXATION DEVICE CONDYLAR PLATE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

PRIMAL OK INTERSPINOUS FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)

FDA 510(k)
FDA Class 2 ·Neurology

GOLDEN COMFORTER

FDA Adverse Event
Malfunction ·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012

IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 20, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 10, 2011

4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

FDA Adverse Event
Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·August 12, 2016

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWC·October 1, 2015

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021