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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
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FMZ. Advisory committee: General Hospital. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: QVF. Advisory committee: Microbiology. Type: Dual Track
Supplement type: 30-Day Notice. Product code: NIN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. 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: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: QIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: QWN. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIO. 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: 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