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18,412 catalysts · 4,728 grant · 3,277 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,412 catalysts · 4,728 grant · 3,277 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Product code: SFD. Advisory committee: Neurology. Type: Special
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. — Reason: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment. — Status: Ongoing
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
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 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Port REF: CL2100 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Bag Spike REF: CL-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ChemoLock Bag Spike, 01 units REF: CL-10-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. — Reason: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. — Status: Ongoing
CA grant. $992,425. PI: Theresa Deisher
HD grant. $161,344. PI: James M. Finley
CA grant. $418,152. PI: Don X Nguyen
DK grant. $559,918. PI: Erik Rolando Duboue
HL grant. $690,473. PI: Anne Mentro Fitzpatrick