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calendar

20 catalysts · 17 device 510k · 3 approval

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no tagged catalysts yet

Week of Oct 21, 2024

20
›Oct 23, 2024approval678d ago
BKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →eculizumab biosimilar →fda approvals ↗
›Oct 23, 2024approval678d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ACCORD HLTHCARE. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Oct 23, 2024approval678d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
›Oct 23, 2024device 510k678d agoL&K BIOMED Co., Ltd. — BluEX Lumbar Expandable Cage System (510k cleared)NeuCen BioMed Co Ltd

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoMim Software, Inc. — MIM – Symphony HDR Fusion (510k cleared)ASURE SOFTWARE INC

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoEpic Medical Pte. , Ltd. — ProSeal™ Closed System Bag Access (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoGuangdong Optomedic Technologies, Inc. — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus; TrueFlex Bolus (510k cleared)Medical Care Technologies Inc.

Product code: MUJ. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoDRTECH Corporation — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (510k cleared)

Product code: KPR. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoSpineart SA — Scarlet® AL-T (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoThe Orthopaedic Implant Company — OIC Small / Mini Fragment Plate System (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoScivita Medical Technology Co., Ltd. — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (510k cleared)NewBay Medical Technology Co Ltd

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoParagonix Technologies — KIDNEYvault Portable Renal Perfusion System (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoWeifang Mingliang Electronics Co., Ltd. — Fractional CO2 Laser Therapy System (EXFU CO2) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoImmunodiagnostic Systems Limited — IDS-iSYS Free Testosterone (510k cleared)Transdermal Delivery Solutions Corp

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k678d agoTsk Laboratory International Japan KK — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (510k cleared)

Product code: QYM. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
$AMGN432.42-1.05%
$ASUR8.2700+1.35%
$MDCE0.00020.00%