24 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Audit MicroControls Control FD Assayed Chemistry, Level 1
FDA UDI
AALTO SCIENTIFIC·B085K0311100·
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044202144·90 mL / 45 mL Prefilled Histoware Vials with Caps
CRYSTAL-EEG MODEL 15
FDA 510(k)
FDA Class 2
·Neurology
M2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
UNIVERSAL DRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·April 26, 2013
TRULIGN TORIC IOL
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MJP·August 28, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·August 22, 2022
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·August 22, 2022
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 3, 2018
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 3, 2018
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·June 25, 2018
Catheter, intravascular, therapeutic, short-term less than 30 days
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·November 10, 2022
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
LEGION HK HINGE KNEE SYSTEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025