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calendar

25,951 catalysts · 16,950 approval · 3,627 device 510k · 2,351 grant · 1,190 device recall · 1,071 device pma · 762 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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  • approval16,950
  • device 510k3,627
  • grant2,351
  • device recall1,190
  • device pma1,071
  • recall762
therapy area

no tagged catalysts yet

Week of Feb 17, 2025

37
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: WES PHARMA INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: HIKMA. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 21, 2025approval559d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ETHYPHARM. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: RHODES PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 21, 2025approval559d agoSUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalIGC Pharma, Inc.

Sponsor: BARR. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 21, 2025approval559d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: LANNETT CO INC. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›Feb 21, 2025approval559d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

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

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›Feb 21, 2025approval559d agoANASTROZOLE — FDA approvalANASTROZOLE

Sponsor: HIKMA. Form: TABLET. Route: ORAL

full page →ANASTROZOLE →fda approvals ↗
›Feb 21, 2025device 510k559d agoOrthopediatrics Canada Ulc Dba Pega Medical — Fassier-Duval Telescoping IM System (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoTaiwan Dental Materials Co., Ltd. — TEMP MASTER, PMMA-based dental resin (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoLyma Life , Ltd. — LYMA Laser PRO (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoSpinal Elements, Inc. — Primus Spinal Fixation System (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoExtremity Medical, LLC — Extremity Medical External Fixation System (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoScandiags AG — ScanDiags Ortho L-Spine MR-Q (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoChurch & Dwight Co., Inc. — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) (510k cleared)CHURCH & DWIGHT CO INC /DE/

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoIntradin (Shanghai) Machinery Co., Ltd. — Powered Mobility Scooter (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoVATECH Co., Ltd. — Green X 12 SE (PHT-40CHS) (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoShenzhen Dazhou Medical Technology Co., Ltd. — Synthetic Bone Graft Particulate (510k cleared)Guangzhou Dazhou Biomedical Technology Co Ltd

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoInstitut Straumann AG — Custom Abutments (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoAikenist Technologies Pvt, Ltd. — QuickRad (510k cleared)Pandorum Technologies Pvt Ltd

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoMedicom Asia-Pacific Holdings Ltd. Taiwan Branch. — Medicom Sterilization Pouch and Reel (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoVita Zahnfabrik H.Rauter GmbH & Co. — VITA YZ Multi Translucent (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoRti Surgical, Inc. — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoCepheid — Xpert® FII & FV (510k cleared)

Product code: NPR. Advisory committee: Hematology. Type: Special

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoMaterialise NV — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (510k cleared)MATERIALISE NV

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoShenzhen TPH Technology Co., Ltd. — Wearable breast pump (model W8) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoShanghai Jianzhong Medical Packaging Co., Ltd. — Sterilization Pouches and Reels (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoProprio, Inc. — Paradigm System (510k cleared)

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

full page →fda device 510k ↗
›Feb 21, 2025device 510k559d agoSonio — Sonio Suspect (510k cleared)

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

full page →fda device 510k ↗

Week of Feb 24, 2025

13
›Feb 24, 2025approval556d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Feb 24, 2025approval556d agoPOSACONAZOLE — FDA approvalPOSACONAZOLE

Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗
›Feb 24, 2025approval556d agoMIUDELLA (COPPER) — FDA approval

Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE

full page →fda approvals ↗
›Feb 24, 2025device 510k556d agoAnqing Clean Dental Instrument Technology Co., Ltd. — Sterilization Package/Reel (510k cleared)

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoLingshi Hongruida Health Protection Technology Co., Ltd. — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoArum Dentistry Co., Ltd. — SD Implant System (510k cleared)

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoAlembic, LLC — APRO 70 Swift Catheter and Alembic Aspiration Tubing (510k cleared)Alembic Pharmaceuticals Inc

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoJpi Healthcare Co, Ltd. — ExamVue Apex (510k cleared)NVP Healthcare Co Ltd

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoTandem Diabetes Care, Inc. — Control-IQ+ technology (510k cleared)TANDEM DIABETES CARE INC

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoOncosoft. Co., Ltd. — OncoStudio (OS-01) (510k cleared)

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

full page →fda device 510k ↗
›Feb 24, 2025device 510k556d agoUlthera, Inc. — Ulthera® System (510k cleared)

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

full page →fda device 510k ↗
›Feb 25, 2025approval555d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Feb 25, 2025device 510k555d agoGE Medical Systems SCS — 3DXR (510k cleared)

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

full page →fda device 510k ↗
← prev
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$IGC0.2670+0.41%
$IGC0.2670+0.41%
$INDV35.05+1.42%
$IGC0.2670+0.41%
$IGC0.2670+0.41%
$MTLS6.5600-1.06%
$FRTRY
$INDV35.05+1.42%
$AMRX18.06+2.15%
$CHD100.09+0.66%
$FRTRY
$TNDM21.09-0.92%