12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODEL 6100 AMBULATORY INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SwishActive™ Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106609·Ø3.7 x 8 Platform 3.5mmD
Alexander SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007534·UR CUSPID -3T 10A .018 (PK5)
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MoisturemeterD
FDA 510(k)
FDA Class 2
·Cardiovascular
EPD 60000 RPM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 27, 2017
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 31, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 18, 2014
PKG, WISE 26IN HDTV SURGICAL DISPLAY
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code GCJ·December 13, 2012
DRILL BIT Ø1.8 F/MATMAND L125 2FLUTE F/0
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZI·September 3, 2013
CABLE 3M TO CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·October 16, 2014
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024