12 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JELCO* DISC FILTER-0.2 MICRON
FDA 510(k)
FDA Class 2
·General Hospital
4CIS® Chiron Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
LAMP, FLOURESCENT BLACK, HIGH OUTPUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·July 27, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 17, 2013
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
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