13 results · 26ms · Sources: EU EUDAMED, US FDA

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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