39 results
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9ms
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Sources: EU EUDAMED, US FDA
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
FDA Enforcement
Class II
·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,L MDTGXP4JXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTGXP4JXXL DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XX MDTL1002862EF DBD-GOWN,SURG,XALT,L4,PANEL CVR,GREEN,XL MDTZ1000893AJ DBD-GOWN,SRG,PNL CVR, GREEN,SNPS,XL
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·March 18, 2026
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
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012