43 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
FDA 510(k)
FDA Class 1
·General Hospital
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000578·MCK Femoral Component
COMPREHENSIVE REVERSE SHOULDER
FDA UDI
Biomet Orthopedics, LLC·00880304477063·
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121265·LOCATOR F-Tx Abutment for 3.3mm Platform Intern...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481121326·LOCATOR R-Tx Abutment for 3.3mm Platform Intern...
BONASTENT® Tracheal/Bronchial
FDA UDI
Sewoon Medical Co., Ltd.·08806369469005·
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FRESENIUS 2008T HEMODIALYSIS MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 24, 2024
COMP PRIMARY STEM 9MM MINI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·February 26, 2018
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 26, 2018
ARCOM XL 44-36 STD +3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 26, 2018
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·February 26, 2018
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 26, 2018
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·January 24, 2019
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 8 MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·July 30, 2021
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
ANCURE ENDOGRAFT
FDA Adverse Event
Injury
·GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·September 26, 2008
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·March 13, 2020