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13,363 catalysts · 3,603 8k filing · 2,401 grant · 2,054 approval · 1,400 device 510k · 1,000 device adverse event · 944 device recall
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13,363 catalysts · 3,603 8k filing · 2,401 grant · 2,054 approval · 1,400 device 510k · 1,000 device adverse event · 944 device recall
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. — Reason: Device packaged in incorrect outer box carton. — Status: Ongoing
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A — Reason: Due to probe bags that may have a compromised or incomplete sterile pouch seal. — Status: Ongoing
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL
Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL
Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS
Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL
Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: FAS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special
Product code: ONB. Advisory committee: General Hospital. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: MQC. Advisory committee: Unknown. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: FFX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: MYE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KXK. Advisory committee: Radiology. Type: Traditional
Product code: JTN. Advisory committee: Microbiology. Type: Traditional
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR
Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR