30 results · 25ms · Sources: EU EUDAMED, US FDA

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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