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29 catalysts · 12 device recall · 9 device 510k · 6 device pma · 2 approval
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29 catalysts · 12 device recall · 9 device 510k · 6 device pma · 2 approval
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: PAW. Advisory committee: Cardiovascular. Type: Traditional
Product code: JNL. Advisory committee: Immunology. Type: Traditional
Product code: MRW. Advisory committee: Unknown. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: HQL. Advisory committee: OP. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MFK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Allwell Inflation Device, for angiographic use REF: IS-30-A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Merit Medical , Custom Manifold Kit REF: K09-13203A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. — Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. — Status: Ongoing
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. — Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. — Status: Ongoing
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Allwell Angioplasty Pack REF: IS-30-B1/B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090 — Reason: Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. — Status: Ongoing
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