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22,322 catalysts · 4,728 grant · 4,117 device 510k · 3,700 8k filing · 3,127 approval · 2,000 device pma · 2,000 device recall
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22,322 catalysts · 4,728 grant · 4,117 device 510k · 3,700 8k filing · 3,127 approval · 2,000 device pma · 2,000 device recall
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: JMT. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DHB. Advisory committee: Immunology. Type: Traditional
Product code: OBO. Advisory committee: Ophthalmic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Abbreviated
Product code: SGX. Advisory committee: General Hospital. Type: Direct
Product code: JOJ. Advisory committee: General Hospital. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: SGW. Advisory committee: Immunology. Type: Direct
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: PZO. Advisory committee: Radiology. Type: Traditional
Product code: KWL. Advisory committee: Orthopedic. Type: Special
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: NGV. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MDP. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LPB. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: QWM. Advisory committee: CV. Decision: OK30
Focalyx Fusion — Reason: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11. — Status: Ongoing
CellMek SPS Sample Preparation System, REF: C44603, with software — Reason: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management. — Status: Ongoing
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08 — Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint — Status: Ongoing
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01. — Reason: Subpotent product:out of specification assay results observed during long term stability testing. — Status: Ongoing
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51. — Reason: Defective container: cracked/broken cartridges — Status: Ongoing