66 results · 23ms · Sources: EU EUDAMED, US FDA

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Lucas Plus

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CoRoent

FDA UDI
Nuvasive, Inc.·00887517570260·CoRoent Ant TLIF Ti, 13x10x34mm 0°

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183778·Integra® Jarit® Liston Bone Cutting Forceps, 5-...

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LOCKING BONE PLATES AND SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 29, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 22, 2024

PRODIGY VOICE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·July 10, 2019

R SERIES DEFBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 21, 2014

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 16, 2013

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·June 19, 2024

TRUEMETRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 31, 2016

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

EQUATE BLOOD GLUCOSE STRIPS

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code CGA·July 7, 2020

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·January 4, 2024

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·May 26, 2022

PRODIGY AUOTCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 1, 2023