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calendar

15 catalysts · 12 device 510k · 3 approval

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no tagged catalysts yet

Week of Dec 9, 2024

15
›Dec 10, 2024approval629d ago
ACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INJECTION

full page →tocilizumab →fda approvals ↗
›Dec 10, 2024approval629d agoACTEMRA (TOCILIZUMAB) — FDA approvaltocilizumab

Sponsor: GENENTECH. Form: INJECTABLE. Route: INTRAVENOUS, SUBCUTANEOUS

full page →tocilizumab →fda approvals ↗
›Dec 10, 2024approval629d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
›Dec 10, 2024device 510k629d agoInstitut Straumann AG — Straumann® PURE Ceramic Implants (510k cleared)

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoIntuitive Surgical, Inc. — IRISeg (510k cleared)INTUITIVE SURGICAL INC

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoCarestream Health, Inc. — DRX-Revolution Mobile X-ray System (510k cleared)HEALTHSTREAM INC

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoJeisys Medical, Inc. — POTENZA (510k cleared)

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoConcourse Assistive Technology Pty, Ltd. — Empulse M90 (510k cleared)

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoAerin Medical, Inc. — Aerin Console (510k cleared)AETHLON MEDICAL INC

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoPhilips Medical Systems Nederland B.V. — Philips IntelliSite Pathology Solution 5.1 (510k cleared)

Product code: PSY. Advisory committee: Pathology. Type: Traditional

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoElos Medtech Pinol A/S — Elos Accurate® Hybrid Base™ (510k cleared)

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoMerit Medical Systems, Inc. — Prelude Small O.D. Introducer Guide Wire (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoAnalog Devices — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (510k cleared)ANALOG DEVICES INC

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoSamsung Medison Co., Ltd. — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (510k cleared)

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

full page →fda device 510k ↗
›Dec 10, 2024device 510k629d agoShantou Institute of Ultrasonic Instruments Co., Ltd. — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (510k cleared)

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

full page →fda device 510k ↗
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$ISRG372.60+1.51%