66 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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