14 results · 20ms · Sources: EU EUDAMED, US FDA

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ZACT DENTAL ARCH TOOTHBRUSCH

FDA 510(k)
FDA Class 1 ·Dental

INTESS CERVICAL CAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN

FDA 510(k)
FDA Class 2 ·Dental

FREE STYLE LIBRE SENSOR

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC.·Product code QBJ·December 23, 2025

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 27, 2014

EPIX UNIVERSAL CLIP APPLIER

FDA Adverse Event
APPLIED MEDICAL·Product code FZP·November 7, 2012

CARELINK

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code KRG·June 10, 2015

FREESTYLE LIBRE 3 SENSORS

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC.·Product code QBJ·August 29, 2024

FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·July 24, 2024

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018