30 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MedicloseTM System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)
EM
FDA UDI
Allied Medical, LLC·00026072025185·TEST LUNG, ADULT
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586029882·
DXS DIGITAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
FDA 510(k)
FDA Class 3
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 24, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
MOTO PARTIAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·November 4, 2025
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R E-CROSS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2023
MOTO PFJ SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 1, 2025
MOTO PARTIAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·April 23, 2026
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·October 27, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 9, 2013
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 31, 2025
DELTEC GRIPPER MICRO NEEDLESS Y-SITE
FDA Adverse Event
Malfunction
·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·January 1, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2025
DELTEC GRIPPER MICRO NEEDLES
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·May 30, 2024
MOTO PFJ SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·May 28, 2026