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13,623 catalysts · 3,312 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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13,623 catalysts · 3,312 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QBA. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QQK. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MNQ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWQ. Advisory committee: CV. Decision: OK30
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5mm, 35 cm, Pistol 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 Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip — Reason: Firm is initiating a removal due to continued reports of adverse events. — Status: Ongoing
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