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calendar

25 catalysts · 22 device 510k · 3 approval

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no tagged catalysts yet

Week of Jan 6, 2025

25
›Jan 10, 2025approval581d ago
FLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗
›Jan 10, 2025approval581d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗
›Jan 10, 2025approval581d agoVEKLURY (REMDESIVIR) — FDA approvalremdesivir

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS

full page →remdesivir →fda approvals ↗
›Jan 10, 2025device 510k581d agoCarl Zeiss Meditec, AG — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoArthrex, Inc. — Arthrex SS VAL and VAL KreuLock™ Compression Screw System (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoAskorn Medical — Universal Tendon Spacer (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoSolo Pace, Inc. — Solo Pace Control (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoImvaria, Inc. — ScreenDx (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoShandong Intco Hygiene Products Co., Ltd. — Unscented Tampon (510k cleared)

Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoBowhead Design Corp. — Bowhead ERA Wheelchairs (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoTools For Surgery, LLC — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoCepheid — Xpert Xpress CoV-2/Flu/RSV plus (510k cleared)

Product code: QOF. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoShenzhen Ulike Smart Electronics Co., Ltd. — Ulike Reglow Light Therapy Device (UM10) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoShenzhen Ruiankang Technology Co., Ltd. — Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoOverfibers S.R.L. — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoErchonia Corporation — Erchonia Zerona® VZ8 (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoPromisemed Hangzhou Meditech Co., Ltd. — Safety Winged Blood Collection Sets (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoApplied BioCode, Inc. — BioCode Gastrointestinal Pathogen Panel (GPP) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoSafecare Biotech (Hangzhou) Co., Ltd. — Safecare Urinary Tract Infection Test (510k cleared)Hangzhou DAC Biotech Co Ltd

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoGlobus Medical, Inc. — NuVasive Pulse System (510k cleared)GLOBUS MEDICAL INC

Product code: OLO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoKlaxon Mobility GmbH — Klaxon (Twist); Klaxon (Twist R) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoTriopsy Medical, Inc. — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoInflammatix, Inc. — TriVerity (510k cleared)

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

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoPerigen, Inc. — PeriCALM Patterns 3.0 (510k cleared)

Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗
›Jan 10, 2025device 510k581d agoVarian Medical Systems, Inc. — Mould Probe MR Safe (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
$MMSI90.72-0.53%
$GILD136.88+0.74%
$GMED79.93+1.27%