14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CHLORIDE REAGENT, CUP & CLEANER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAZOR
FDA UDI
Ortho Arch Company Inc·D90980021715·RAZOR PIN & LIGATURE CUTTER MINIATURE
ACUMED
FDA UDI
Acumed LLC·10806378040573·Broken 2.7 CO Trephine
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418744·Kelly Retractor
51x152...
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
FDA 510(k)
FDA Class 1
·General Hospital
COMPONENT NEUROMONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BROKEN 2.7 CO TREPHINE
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code HTW·April 22, 2022
BROKEN 2.7 CO TREPHINE
FDA Adverse Event
Malfunction
·ACUMED, LLC·Product code HTW·April 22, 2022
USS-VAS Ø6.2 L40 TAN DBLUE
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·May 8, 2014
HILL-ROM 100 LOW BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 8, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·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
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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