24 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED
Portex
FDA UDI
ICU MEDICAL, INC.·10351688413932·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688405401·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688410801·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688403148·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688404152·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688403728·
Portex
FDA UDI
ICU MEDICAL, INC.·10351688408976·
Tuxedo Digital Dental Sensor
FDA 510(k)
FDA Class 2
·Radiology
Storz Medical MAGNETOLITH Muscle Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·July 27, 2017
Portex
FDA UDI
ICU MEDICAL, INC.·15019315060229·
Truliant
FDA UDI
Exactech, Inc.·10885862556905·TRULIANT CC INSRT TOPPER SIZE 1 THIN
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 3, 2018
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 3, 2018
VITALITY 2 VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·August 10, 2011
MBT CEM KEEL TIB TRAY SZ5
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·July 30, 2013
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