13 results
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18ms
·
Sources: EU EUDAMED, US FDA
VENTRE/SEP T3 UPTAKE RADIOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408753·
THD N-ano anoscope
FDA UDI
THD SPA·08033737710715·The THD N-ano anoscope is a disposable medical ...
0800,APS1,08,N,LF,LO,VL,CH
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152884·0800,APS1,08,N,LF,LO,VL,CH
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809736·Twist Lock, 20cc BD
KORONA
FDA UDI
HNM TOTAL RECON LLC·00841742100661·KORONA Quad Staple - (L)10mm, 18mmx16mm
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
FDA 510(k)
FDA Class 1
·General Hospital
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General Hospital
AXIUM PLATINUM HELICAL DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·May 8, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 29, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018