41 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PURESLEEP
FDA 510(k)
FDA Class 2
·Dental
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304212183·
8920 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136020532·8920 ADULT LG MASK W/2630 2W
Comprehensive Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00880304681019·
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642103984·LP Cross Connector Large
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1430220·Rod Cutter, Table Top
0113022
FDA Adverse Event
Malfunction
·BURTON MEDICAL PRODUCTS·Product code FQP·August 30, 1996
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
FDA 510(k)
FDA Class 2
·Cardiovascular
KIM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 16, 2026
SUPERIOR END PLATE MEDIUM 6°-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·May 15, 2013
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014
FORCE TRIVERSE ES DEVICE COATED BLADE
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·May 25, 2011
HYBRID GLENOID BASE SMALL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 8, 2018
SMALL HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·August 13, 2018
COMPREHENSIVE SHOULDER SYSTEM HYBRID GLENOID BASE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·September 8, 2025
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019
PT HYBRID GLEN POST REGENEREX
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 2, 2017