9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Orthopedic Extension
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761972131·Spindle traction mechanism FR
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761991545·Trumpf Medical/Medizin Spindle traction mechani...
Disposable Temperature Probe
FDA 510(k)
FDA Class 2
·General Hospital
HEMODIALYSIS CONCENTRATE, SODIU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 18, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·October 12, 2010
VICTORY XL DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·December 20, 2012
Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009