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calendar

25,484 catalysts · 16,885 approval · 3,555 device 510k · 2,327 grant · 1,041 device pma · 926 device recall · 750 recall

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2026-08-31: 0 catalysts2026-09-01: 0 catalysts2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 1 catalyst2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts2026-11-09: 1 catalyst2026-11-10: 0 catalysts2026-11-11: 0 catalysts2026-11-12: 0 catalysts2026-11-13: 0 catalysts2026-11-14: 0 catalysts2026-11-15: 0 catalysts2026-11-16: 0 catalysts2026-11-17: 0 catalysts2026-11-18: 0 catalysts2026-11-19: 0 catalysts2026-11-20: 0 catalysts2026-11-21: 0 catalysts2026-11-22: 0 catalysts2026-11-23: 0 catalysts2026-11-24: 0 catalysts2026-11-25: 0 catalysts2026-11-26: 0 catalysts2026-11-27: 0 catalysts2026-11-28: 0 catalysts2026-11-29: 0 catalysts
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  • approval16,885
  • device 510k3,555
  • grant2,327
  • device pma1,041
  • device recall926
  • recall750
therapy area

no tagged catalysts yet

Week of Nov 18, 2024

50
›Nov 20, 2024device 510k652d agoIndiba S. A. U. — INDIBA COMPACT devices (510k cleared)

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

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoPro Surgical, Inc. — ProAM ACDF System (510k cleared)

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

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoOsstem Implant Co., Ltd. — Estar-ZE (510k cleared)

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

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoExo, Inc. — Strain AI (SAI001) (510k cleared)

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

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoShenzhen Ruiyi Business Technology Co., Ltd. — Leg Massager (Models:RP-ALM070H, RP-ALM071H) (510k cleared)

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

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoGostar Co., Ltd. — TD-7301 Spirometer (TD-7301) (510k cleared)

Product code: BZG. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoQ'Apel Medical, Inc. — Neurovascular Access System Family (510k cleared)

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

full page →fda device 510k ↗
›Nov 20, 2024device 510k652d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red Light Hat (HG-120K) (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024approval651d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 21, 2024approval651d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗
›Nov 21, 2024approval651d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗
›Nov 21, 2024approval651d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗
›Nov 21, 2024approval651d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

full page →hydrocodone bitartrate ER →fda approvals ↗
›Nov 21, 2024approval651d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗
›Nov 21, 2024approval651d 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 ↗
›Nov 21, 2024approval651d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
›Nov 21, 2024approval651d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval651d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →hydrocodone bitartrate ER →fda approvals ↗
›Nov 21, 2024approval651d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

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

full page →fda approvals ↗
›Nov 21, 2024device 510k651d agoFink Engineering Pty, Ltd. — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (510k cleared)

Product code: CBF. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoVarian Medical Systems, Inc. — Gating Reflector Block (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoLifenet Health — PliaFX Flo (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoIlooda Co,., Ltd. — Secret MAX Multi-platform RF System (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Mini and Micro Plating System (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoGeneral Vibronics, Inc. — MIRARI® Cold Plasma System ( GV-M2-01) (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoSurGenTec, LLC — TiLink-P Joint Fusion System (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoShenzhen Smallsignal Technology Co., Ltd. — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoColoplast Corp. — Luja Coude (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoJazz Imaging — Jazz Classic (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoCepheid® — Xpert vanA (510k cleared)

Product code: NIJ. Advisory committee: Microbiology. Type: Special

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoDepuy Ireland UC — ATTUNE™ Revision Hinge Knee (510k cleared)

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

full page →fda device 510k ↗
›Nov 21, 2024device 510k651d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Ankle Plating System (510k cleared)

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

full page →fda device 510k ↗
›Nov 22, 2024approval650d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗
›Nov 22, 2024approval650d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 22, 2024approval650d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 22, 2024approval650d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

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

full page →mosunetuzumab →fda approvals ↗
›Nov 22, 2024approval650d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
›Nov 22, 2024device 510k650d agoFlower Orthopedics Corporation Dba Conventus Flower Ortho — OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (510k cleared)

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

full page →fda device 510k ↗
›Nov 22, 2024device 510k650d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (510k cleared)

Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024device 510k650d agoXf Agencija Limited — Nooro Body & Foot Stimulator (SM9141, SM9142) (510k cleared)

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

full page →fda device 510k ↗
›Nov 22, 2024device 510k650d agoAdvamedix, GmbH — Suction Irrigation Tubing Set (510k cleared)

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

full page →fda device 510k ↗
›Nov 22, 2024device 510k650d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

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

full page →fda device 510k ↗
›Nov 22, 2024device 510k650d agoNova Biomedical Corporation — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (510k cleared)

Product code: LCP. Advisory committee: Hematology. Type: Dual Track

full page →fda device 510k ↗
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