41 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIAFIL & DIAFIL Capsule
FDA 510(k)
FDA Class 2
·Dental
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074520582·SPACER 9192510 CRESCENT PEEK 25X10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198734·AK3 Ultra Insert Trial Size 5, 10mm
Symetri Clear
FDA UDI
ORMCO CORPORATION·00889989083002·U4&5R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVI...
Echo® Press-Fit Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260858·
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868273933·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463134·
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780506140·Integra® Miltex® House Barbara Pick, 6-1/4", St...
DIMENSIONS HB1C KIT, MODEL DF105A
FDA 510(k)
FDA Class 2
·Hematology
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
FDA 510(k)
FDA Class 2
·Cardiovascular
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108153·TRIAL 90-SRK-192510 POLY-MPCS 5X10 LEFT
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·March 31, 2022
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 22, 2014
CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L5
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JEY·June 27, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 22, 2018
ACT ARTIC E1 HIP BRG 28X46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 22, 2018
VNGD POST FEM AUG 70X10 LL/RM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019
VNGD DIST FEM AUG 70X15 LL/RM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 19, 2019