12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMUNOCAP ALLERGEN K82
FDA 510(k)
FDA Class 2
·Immunology
Spherodon - M
FDA UDI
SILMET LTD·07290012207297·Dental Amalgam Capsules
MaxFuse VBR, 10 (D) x 12 (W) x 64 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055837·10 (D) x 12 (W) x 64 (H)
MODEL 1133 IVD PC VERSION
FDA 510(k)
FDA Class 2
·Radiology
VALEO VT-601 SERIES IR THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064979·Corpectomy, 12Dx14Wx63H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929045183·Corpectomy, 12Dx14Wx63H 6°
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 7, 2011
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
NORTH HAVEN - USS·Product code GDW·August 13, 2008
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025