20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Peel-Away Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
2.0 x 130mm Drill Bit Calibrated
FDA UDI
Osteocentric Technologies, Inc.·00816950029516·2.0 x 130mm Drill Bit Calibrated
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108695649·Dynamic Dental Implant Ø3.25mm L13mm
LEONE SPA
FDA UDI
LEONE SPA·08033707018070·CALIBRA 1ST MOLAR BANDS n.LL 20
Ø3.5mm x 20mm Precontoured Cervical Rods
FDA UDI
XENCO MEDICAL LLC·B064XM21700201·
Ø3.5mm X 20mm PRECONTOURED CERVICAL RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21700202·
DX SERIES FINGER SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COMCASET-P SAFETY IV CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code MLV·March 25, 2022
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code MLV·March 25, 2022
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code MLV·May 7, 2022
Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L
FDA UDI
A-M SYSTEMS, LLC·00817081025644·Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·October 14, 2014
MESH-COMPOSIX
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·July 12, 2011
MEDTRONIC MINIMED PARADIGM523
FDA Adverse Event
Injury
·MEDTRONIC·Product code LZG·June 10, 2013
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
FDA Recall
Terminated
·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code DZE·November 18, 2019
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
FDA Enforcement
Class II
·Terminated·Paltop Advanced Dental Solutions Ltd·January 29, 2020
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 4, 2026
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024