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14,388 catalysts · 3,350 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
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14,388 catalysts · 3,350 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Sponsor: CADILA. Form: TABLET. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AZURITY. Form: SOLUTION. Route: ORAL
Sponsor: DR REDDYS LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: INTRAVENOUS
Sponsor: MYLAN PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTABLE. Route: INJECTION
Sponsor: RISING. Form: INJECTABLE. Route: INJECTION
Sponsor: ROYAL PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: INGENUS PHARMS LLC. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: CREAM. Route: TOPICAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: SOLUTION. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: ACTAVIS LABS FL. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: OLR. Advisory committee: Unknown. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NGV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. 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: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MLV. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DYE. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NZK. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Cardiosave Rescue — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing
Cardiosave Hybrid — Reason: The IFU addendum updates the Vibration and Shock Table to reference the correct standards. — Status: Ongoing
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; — Reason: The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used. — Status: Ongoing
Sponsor: ARS PHARMS OPERATION. Form: SPRAY. Route: NASAL