124 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.
FDA Enforcement
Class II
·Ongoing·Alphatec Spine, Inc.·February 5, 2025
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·April 12, 2023
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·April 12, 2023
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·April 12, 2023
Plum Duo Precision IV Pump, 40002-0403
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Plum Duo Infusion Pump, 40002-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Plum Solo Precision IV Pump, 40001-0401
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·June 17, 2026
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 27, 2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·January 21, 2026
Portex Spinal Tray, Item No. A3729-24 A3595
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·January 21, 2026
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
Plum Duo Infusion System, List Number 40002-04-01
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 21, 2026
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·January 28, 2026
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·December 31, 2025
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·November 5, 2025