23 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
FDA 510(k)
FDA Class 2
·Immunology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040066031·Gates Glidden Drills RA 32mm
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00271071·
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002107·artVeneer life lower posteriors, S, C2
BetaForce™
FDA UDI
Ortho Organizers, Inc.·00190707124373·BETAFORCE Beta³ Upper 16x22 (10pk)
BetaForce
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730021960·Beta3 Upper 16x22 10 archwires per pack
BD NEEDLE 18X1-1/2 BLUNT FILL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·December 5, 2025
SERVO-I BASE UNIT
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·December 19, 2024
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
FDA 510(k)
FDA Class 2
·Cardiovascular
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY·Product code GAA·June 30, 2025
CARDIOSAVE HYBRID, TYPE I PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·April 8, 2026
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·February 11, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·February 4, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2008
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 28, 2025
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026