17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LnK Lumbar Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704630858·Rusch Polaris FO Blade, Mac 4, Sterile
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304241251·
BLT Profile Drill, long
FDA UDI
BIO CONCEPT Co., Ltd.·06947600304142·
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095620215·Pipette tip, 5-200uL, natural for MLA
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192404·Apex Revision Knee Reamer - Zimmer 14mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046794·PrimaLIF LLIF PEEK Implant, 11mm X 18mm X 40mm,...
PROLYTE ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DENTLIGHT ORAL EXAM LIGHT KIT
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
GENDRON, INC.·00842307103042·STRETCHER,CHR FRM,ENAM LTR
ACCENT DR RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011
M2A MAGNUM MODULAR HEAD COCR DIA 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 6, 2017
COBAS 8000 COBAS ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014