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17,794 catalysts · 4,728 grant · 3,126 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
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17,794 catalysts · 4,728 grant · 3,126 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
LM grant. $365,103. PI: Yanshan Wang
NS grant. $1,443,561. PI: Susan L Ingram
AI grant. $306,872. PI: Amy J Powless
HL grant. $306,872. PI: Yi-An Hsieh
HD grant. $846,528. PI: Chadi A. Calarge
DK grant. $350,000. PI: Buel Rodgers
GM grant. $349,801. PI: Christopher R. Lucas
DK grant. $2,736,640. PI: Jennifer Kaoru Bando
DK grant. $756,480. PI: SRIDHARAN RAGHAVAN
AR grant. $746,572. PI: Nicole R LeBoeuf
AR grant. $596,189. PI: Hannah Jean Lundberg
GM grant. $349,855. PI: Kaustubh Kale
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy. — Reason: Potential for compromised integrity of the sterile packaging. — Status: Ongoing
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft. — Reason: Potential for compromised integrity of the sterile packaging. — Status: Ongoing
DK grant. $779,978. PI: Minal R Patel
HD grant. $344,356. PI: Chen Yu
HD grant. $1,130,572. PI: JOHN J FOXE
Supplement type: Normal 180 Day Track. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR
AR grant. $314,362. PI: Fioleda Prifti Kesseli
DK grant. $2,381,683. PI: Ming He
DK grant. $75,520. PI: Lauren Nicole Lucas
HL grant. $76,819. PI: Jose R Medina Inojosa
DK grant. $2,559,138. PI: David Michael Merrick
DK grant. $372,067. PI: Christopher Shen
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QTZ. Advisory committee: Radiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
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