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46,317 catalysts · 18,987 approval · 7,208 phase readout · 5,000 device 510k · 4,728 grant · 3,603 8k filing · 2,000 device pma

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  • approval18,987
  • phase readout7,208
  • device 510k5,000
  • grant4,728
  • 8k filing3,603
  • device pma2,000
  • device recall2,000
recall1,126
  • device adverse event1,000
  • earnings585
  • therapy area
    • Oncology148
    • Infectious Disease46
    • Cardiology37
    • Immunology35
    • Dermatology31
    • Pulmonology22
    • Women's Health19
    • Ophthalmology16
    • Pain15

    Week of Apr 28, 2025

    29
    ›May 1, 2025device 510k486d agoInnovative Sterilization Technologies — ONE TRAY® Sealed Sterilization Container System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoShenzhen Qianyu Technology Co., Ltd. — Wrinkle Treatment Device (JM1, JM2B) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoAlembic, LLC — APRO 45 Catheter (510k cleared)Alembic Pharmaceuticals Inc

    Product code: DQY. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoParagon 28, Inc. — APEX 3D Total Ankle Replacement System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoCepheid® — Xpert Xpress CoV-2/Flu/RSV plus (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoTraferox Technologies, Inc. — X°Port Lung Preservation System; X°Port Lung Preservation Solution (510k cleared)TETRA TECHNOLOGIES INC

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoBioHorizons Implant Systems, Inc. — Conical Ti Base abutments (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoUnited Orthopedic Corporation — Resolve Modular Revision Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoCirca Scientific, Inc. — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (510k cleared)Clear Scientific Inc

    Product code: DXF. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›May 1, 2025device 510k486d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vscan Air (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025approval485d agoTICAGRELOR — FDA approvalTICAGRELOR

    Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

    full page →TICAGRELOR →fda approvals ↗
    ›May 2, 2025device 510k485d agoPfm Medical, Inc. — JetCan® Pro Safety Huber Needle (510k cleared)Picard Medical, Inc.

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoShockwave Medical, Inc. — Shockwave CS Guide Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoHathor Professional Skincare , Ltd. — Sutil Rich Personal Lubricant (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoSignature Orthopaedics Pty, Ltd. — Origin™ Cemented Hip Stem (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoBeijing Rongrui-Century Science & Technology Co., Ltd. — SpO2 Extension Cable (510k cleared)

    Product code: DSA. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoAbbott Point of Care, Inc. — i-STAT CG4+ cartridge with the i-STAT 1 System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoSg Endoscopy Pte, Ltd. — F88 URE-SD/RD Flexible Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoSTERIS Corporation — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (510k cleared)STERIS plc

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoSeriously Clean, Ltd. — Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (510k cleared)

    Product code: FRO. Advisory committee: Unknown. Type: Traditional

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoAtsens Co., Ltd. — AT-Patch (ATP-C130/ATP-C70) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoMedical Electronic Systems , Ltd. — SQA-iOw Sperm Quality Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoCionic, Inc. — CIONIC NEURAL SLEEVE (NS-200) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoSkydance Vascular, Inc. — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoIntradys — LUMYS (V1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoShenzhen AOJ Medical Technology Co., Ltd. — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (510k cleared)NewBay Medical Technology Co Ltd

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoKarl Storz SE & CO. KG — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoBrightheart — Fetal EchoScan (v1.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 2, 2025device 510k485d agoMomentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (510k cleared)

    Product code: QNM. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗

    Week of May 5, 2025

    21
    ›May 5, 2025approval482d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

    full page →fda approvals ↗
    ›May 5, 2025approval
    ← prev
    page 371 of 927
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    482d ago
    FENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

    Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

    full page →LEUPROLIDE ACETATE →fda approvals ↗
    ›May 5, 2025device 510k482d agoZamar Medical D.O.O. — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoAevice Health Pte. , Ltd. — AeviceMD (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoGenoss Co., Ltd. — Bluemoon (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoPhilips Medizin Systeme Böblingen GmbH — Telemetry Monitor 5500 Release 4.0 (867232) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoThermasolutions, LLC — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoPearl, Inc. — Second Opinion® Pediatric (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoAsiga Pty, Ltd. — DentaTOOTH (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoArthrex, Inc. — Arthrex Synergy Vision Endoscopic Imaging System (510k cleared)

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

    full page →fda device 510k ↗
    ›May 5, 2025device 510k482d agoDae Myung Chemical Co., Ltd. (Vietnam) — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025approval481d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

    Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

    full page →tramadol hydrochloride ER →fda approvals ↗
    ›May 6, 2025device 510k481d agoMentice Spain S.L. — ANKYRAS (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k481d agoWontech Co., Ltd. — Alma Veil (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k481d agoSolutions For Tomorrow AB — !M1 (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k481d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Ureteroscope (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k481d agoFoshan Newface Electronic Technology Co., Ltd. — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 6, 2025device 510k481d agoDongguan Boyuan Intelligent Technology Co.,Ltd — IPL Hair Removal Device (KCA511/KCA516/KCA522) (510k cleared)

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

    full page →fda device 510k ↗
    ›May 7, 2025approval480d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

    Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS

    full page →risankizumab →fda approvals ↗
    ›May 7, 2025approval480d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

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

    full page →risankizumab →fda approvals ↗
    ›May 7, 2025recall480d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17 — Reason: Subpotent — Status: Ongoing

    full page →fda recalls ↗
    $STE233.78+0.35%
    $FRTRY
    $TTI
    $PMI0.1821-4.66%
    $ABBV255.48-1.03%
    $ABBV255.48-1.03%
    $HCA417.82-0.36%