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calendar

22 catalysts · 15 device 510k · 7 approval

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  • device 510k15
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no tagged catalysts yet

Week of Oct 7, 2024

22
›Oct 10, 2024approval691d ago
ITOVEBI (INAVOLISIB) — FDA approvalinavolisib

Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

full page →inavolisib →fda approvals ↗
›Oct 10, 2024approval691d agoEYLEA HD (AFLIBERCEPT) — FDA approvalEYLEA HD

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →EYLEA HD →fda approvals ↗
›Oct 10, 2024approval691d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 10, 2024approval691d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗
›Oct 10, 2024approval691d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗
›Oct 10, 2024approval691d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗
›Oct 10, 2024approval691d agoIMULDOSA (USTEKINUMAB-SRLF) — FDA approvalustekinumab biosimilar

Sponsor: ACCORD BIOPHARMA INC.. Form: INJECTABLE. Route: INTRAVENOUS

full page →ustekinumab biosimilar →fda approvals ↗
›Oct 10, 2024device 510k691d agoGreens Surgicals Pvt. , Ltd. — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoEpic Medical Pte. , Ltd. — ProSeal™ In Line Pump Set (423850) (510k cleared)

Product code: ONB. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoBausch & Lomb, Incorporated — EyeGility™ Inserter for Preloaded enVista IOLs (510k cleared)Bausch & Lomb Corp

Product code: MSS. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoHeartLung Corporation — AutoChamber (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoYilink (Tianjin) Biotechnology Co., Ltd. — Dental porcelain powder (510k cleared)

Product code: EIH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoSiemens Healthcare Diagnostics Products GmbH — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (510k cleared)Taho Pharmaceuticals Ltd

Product code: QLU. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoCtl Medical Corporation — KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (510k cleared)

Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoIcardio.Ai — EchoMeasure (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoB.T.I. Biotechnology Institute, Sl. — BTI Interna 3.0 Dental Implant System UnicCa® (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoBLUECORE COMPANY Co., Ltd. — Lasya-Trinity (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoStryker Corporation (Tornier, S.A.S.) — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid (510k cleared)

Product code: PHX. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoShanghai United Imaging Healthcare Co., Ltd. — uDR 380i Pro (510k cleared)

Product code: IZL. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoQuanta System Spa — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoWeero Co., Ltd. — eMVFit (MVF-10M) (510k cleared)

Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›Oct 10, 2024device 510k691d agoAmbu A/S — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (510k cleared)

Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗
$BLCO17.15+0.12%
$REGN794.19-1.67%
$ABVC