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19,210 catalysts · 4,728 grant · 3,230 8k filing · 2,681 approval · 2,496 device 510k · 2,000 device recall · 1,747 device pma
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19,210 catalysts · 4,728 grant · 3,230 8k filing · 2,681 approval · 2,496 device 510k · 2,000 device recall · 1,747 device pma
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. — Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. — Status: Ongoing
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
GE HealthCare OEC 9900 Elite C-arm Systems. — Reason: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user. — Status: Ongoing
GE HealthCare OEC 9800. — Reason: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user. — Status: Ongoing
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 — Reason: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. — Status: Ongoing
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBF. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: IWB. Advisory committee: Radiology. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Special
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ITX. Advisory committee: Radiology. Type: Traditional
Product code: KJJ. Advisory committee: Unknown. Type: Traditional
Product code: PZL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: CAF. Advisory committee: Anesthesiology. Type: Traditional
Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL
Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: PGQ. Advisory committee: EN. Decision: APPR
Supplement type: Panel Track. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: MHE. Advisory committee: EN. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: MKJ. Advisory committee: CV. Decision: APPR