9 results
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16ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·August 14, 2024
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·January 17, 2024
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
FDA Enforcement
Class II
·Terminated·Stryker Spine·October 17, 2018
NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 13, 2019
Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113A
FDA Enforcement
Class II
·Ongoing·Getinge Usa Sales Inc·January 24, 2024
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021