29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
5530 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021652·5530 HRI 3L CAL SYR W/NDD OUTL
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304204515·
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046371435·Rotary diamond instrument for dental application
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·57291046251879·FG Rotary diamond instrument for dental applica...
SOFTIQUE, MODEL GI 11001
FDA 510(k)
FDA Class 2
·Physical Medicine
VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·May 8, 2026
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·April 3, 2026
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
DURAGEN PLUS DURAL REGENERATION MATRIX 1X1 1PAC
FDA Adverse Event
Injury
·PLAINSBORO CORPORATE OFFICE·Product code GXQ·May 10, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 2, 2011
BIO-MODULAR HUMERAL HEAD 44MM DIA X 17 MM NECK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 14, 2017
BIO-MODULAR GLENOID 7MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 14, 2017
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·November 26, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·August 20, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·July 22, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025
ALINITY I HAVAB-IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·June 25, 2025