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20 catalysts · 10 device pma · 8 device 510k · 1 approval · 1 device recall
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20 catalysts · 10 device pma · 8 device 510k · 1 approval · 1 device recall
Sponsor: ZYDUS LIFESCIENCES. Form: TABLET. Route: ORAL
Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: NRA. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKT. Advisory committee: MI. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NRA. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIQ. Advisory committee: CV. Decision: OK30
FloPatch FP120, REF: FP120-FOT01-005 — Reason: Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. — Status: Ongoing
Product code: QPL. Advisory committee: Neurology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GXD. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QEB. Advisory committee: Anesthesiology. Type: Traditional