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calendar

30 catalysts · 25 device 510k · 5 approval

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  • device 510k25
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no tagged catalysts yet

Week of Oct 7, 2024

30
›Oct 11, 2024approval690d ago
METHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 11, 2024approval690d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 11, 2024approval690d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: IPCA LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 11, 2024approval690d agoHYMPAVZI (MARSTACIMAB-HNCQ) — FDA approvalmarstacimab

Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →marstacimab →fda approvals ↗
›Oct 11, 2024approval690d agoDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE) — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 11, 2024device 510k690d agoBeckman Coulter, Inc. — Access Toxo IgM II (510k cleared)

Product code: LGD. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoOrmco Corporation — Spark™ Clear Aligner System (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoAiros Medical, Inc. — ARTAIRA Arterial Compression Device (AACD01) (510k cleared)AVANOS MEDICAL, INC.

Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoQx World, Ltd. — QUEX ED; QUEX S (510k cleared)

Product code: OMC. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoAnhui Deepblue Medical Technology Co., Ltd. — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (510k cleared)

Product code: LCX. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoProgressive Aligners, Inc. — Progressive Orthodontics App (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoAccure Acne, Inc. — Accure Laser System (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoSterilmed, Inc. — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter (510k cleared)

Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoDongguan Tutamen Metalwork Co., Ltd. — PBM Hair Therapy Cap (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoJdentalcare Srl — JDZygoma dental implants (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoCopan Italia Spa — UriSponge™ (510k cleared)

Product code: JSM. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoFujifilm Corporation — Hood (DH-083ST) (510k cleared)Fujifilm Holdings Corp

Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoHeidelberg Engineering GmbH — SPECTRALIS with Flex Module (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoSiemens Medical Solutions USA, Inc. — syngo Application Software (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoDongguan Boyuan Intelligent Technology Co.,Ltd — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoPermantis Public Health — PPH Saliva Collection Kit (510k cleared)

Product code: QBD. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoSTERIS Corporation — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (510k cleared)STERIS plc

Product code: ODC. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoOrtho Development Corp. — Legend® Acetabular Shell (510k cleared)DeFi Development Corp.

Product code: LPH. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoBelun Technology Company Limited — Belun Ring BLR-200 (BLR-200) (510k cleared)

Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoCmr Surgical Limited — Versius Surgical System (510k cleared)

Product code: SCV. Advisory committee: General, Plastic Surgery. Type: Direct

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoSamsung Medison Co., Ltd. — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoPeters Surgical — Monotime and Optime R (510k cleared)

Product code: GAM. Advisory committee: General, Plastic Surgery. Type: Abbreviated

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoZhejiang Innuovo Rehabilitation Devices Co.,Ltd — Mobility Scooter (N3473) (510k cleared)

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

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoQpix Solutions, Inc. — X Sensor (Model: IOS-A15IF, HDI-15DGF) (510k cleared)UL Solutions Inc.

Product code: MUH. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗
›Oct 11, 2024device 510k690d agoCenterline Biomedical, Inc. — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) (510k cleared)

Product code: DQK. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
$PFE27.96-0.21%
$STE233.78+0.35%
$AVNS
$ULS
$PFE27.96-0.21%
$DFUKF
$PFE27.96-0.21%
$ANIP72.83-0.93%