19 results
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36ms
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Sources: EU EUDAMED, US FDA
MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78601031·Sprint II Bracket Roth .018" max. 1 right
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190813·FEMORAL CUT TEST GAGE SZ 4-5
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981160142·Plate Template, Flat
R82
FDA UDI
R82 A/S·05707292577658·
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78601030051·Sprint II Bracket Roth .018" max. 1 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78601030101·Sprint II Bracket Roth .018" max. 1 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78601031001·Sprint II Bracket Roth .018" max. 1 right
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860103000·Standard Band, Tooth 15-14/24-25, Size 3
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860103220·Standard Band, Tooth 15-14/24-25, Size 3/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011860103180·Standard Band, Tooth 15-14/24-25, Size 3/Roth 18
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
Spetzler Malis Dual Illuminating Bipolar Forceps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 7, 2010
T.W. POWER SUPPLY
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 21, 2012
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012