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5,011 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,686 phase readout · 2,363 8k filing · 2,000 device pma

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2026-07-20: 0 catalysts2026-07-21: 0 catalysts2026-07-22: 30 catalysts2026-07-23: 2 catalysts2026-07-24: 1 catalyst2026-07-25: 0 catalysts2026-07-26: 0 catalysts2026-07-27: 2 catalysts2026-07-28: 4 catalysts2026-07-29: 12 catalysts2026-07-30: 12 catalysts2026-07-31: 3 catalysts2026-08-01: 0 catalysts2026-08-02: 0 catalysts2026-08-03: 4 catalysts2026-08-04: 12 catalysts2026-08-05: 14 catalysts2026-08-06: 10 catalysts2026-08-07: 1 catalyst2026-08-08: 0 catalysts2026-08-09: 0 catalysts2026-08-10: 1 catalyst2026-08-11: 1 catalyst2026-08-12: 1 catalyst2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 0 catalysts2026-08-18: 1 catalyst2026-08-19: 0 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 0 catalysts2026-08-27: 0 catalysts2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 0 catalysts2026-09-02: 0 catalysts2026-09-03: 0 catalysts2026-09-04: 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: 0 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: 0 catalysts2026-10-01: 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: 0 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 0 catalysts2026-10-14: 0 catalysts2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts
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type: patent expiry×type: device 510k×clear all
type
  • approval18,987
  • device 510k5,000
  • grant4,728
  • phase readout4,686
  • 8k filing2,363
  • device pma2,000
device recall
2,000
  • recall1,126
  • device adverse event1,000
  • earnings292
  • therapy area
    • Infectious Disease9
    • Oncology2
    • Dermatology1
    • Pulmonology1

    Week of Sep 23, 2024

    25
    ›Sep 26, 2024device 510k665d agoAccelerate Diagnostics, Inc. — Accelerate Arc System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2024device 510k665d agoMolli Surgical, Inc. — MOLLI 2 System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 26, 2024device 510k665d agoSpineguard — Cannulated PsiFGuard (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoHangzhou AllTest Biotech Co., Ltd. — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (510k cleared)Hangzhou DAC Biotech Co Ltd

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoWestridge Laboratories, Inc. — ID Free Personal Lubricant (510k cleared)G&W Laboratories Inc

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoBrain Electrophysiology Laboratory Company, LLC — Sourcerer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoShockwave Medical, Inc. — Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

    Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoNanosonics Limited — trophon Wireless Ultrasound Probe Holder (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoOptmed, Inc. — TearRepair Liquid Skin Protectant (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoResmed Corp — EasyCare Tx 2 (510k cleared)RESMED INC

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoChiaro Technology, Ltd. — Elvie Stride 2 (510k cleared)U-BX Technology Ltd.

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoIcare Finland OY — iCare ST500 (TA04) (510k cleared)

    Product code: HKY. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoAit Austrian Institute of Technology GmbH — encevis (2.1) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoDaeju Meditech Engineering Co., Ltd. — ACTIVO (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoAmc Health — AMC Health CareConsole (510k cleared)AOP Health

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoHyundae Meditech Co., Ltd. — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoPi-Cardia, Ltd. — ShortCut (510k cleared)

    Product code: SCZ. Advisory committee: Cardiovascular. Type: Direct

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoBunkerHill Health — CAC (gated) Algorithm (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoBalt USA, LLC — Optima Coil System (OptiBlock Line Extension) (510k cleared)Bayer USA LLC

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red and Infrared Light Mask (MK66-L) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoJLK, Inc. — JBS-LVO (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoTaiwan Aulisa Medical Devices Technologies, Inc. — Aulisa Temperature Module (TM0002) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoInari Medical, Inc. — ClotTriever XL Catheter (41-102) (510k cleared)Mobia Medical, Inc.

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

    full page →fda device 510k ↗
    ›Sep 27, 2024device 510k664d agoMedline Industries, LP — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (510k cleared)

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

    full page →fda device 510k ↗

    Week of Sep 30, 2024

    25
    ›Sep 30, 2024device 510k661d agoKem Medical Products Corporation — Kem Medical Lead-free Chemical Indicators for Steam Sterilization (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k
    ← prev
    page 1 of 101
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    661d ago
    Dentalmax Co., Ltd. — LUXEN 5G (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoMikron Makina Sanayi VE Ticaret Ltd. Sti. — MSFX MIKRON SPINAL FIXATION SYSTEM (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoRecensmedical, Inc. — OcuCool (510k cleared)

    Product code: QZQ. Advisory committee: Unknown. Type: Direct

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoYsi, Inc. — YSI 2900C Biochemistry Analyzer (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoGuangzhou Wondfo Biotech Co., Ltd. — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoMicroPort NeuroTech (Shanghai) Co., Ltd. — Numen™ Coil Embolization System; NumenFR™ Detachment System (510k cleared)

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoProcept Biorobotics — AQUABEAM Robotic System (AB2000) (510k cleared)PROCEPT BioRobotics Corp

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

    full page →fda device 510k ↗
    ›Sep 30, 2024device 510k661d agoVantis Vascular, Inc. — CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoWallaby Medical — Esperance 3+ Aspiration Catheter System (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoSpringbok, Inc. — MuscleView (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoBodyvision Medical , Ltd. — LungVision (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoYongkang Youha Electric Appliance Co., Ltd. — Electric wheelchair (YHWL002, YHWL003) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoGe Hualun Medical Systems Co. , Ltd. — Definium Pace Select ET (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoSamsung Electronics Co., Ltd. — GM85 (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Disposable Endoscope Valves Set (AF series) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoAicheck Biotech, Inc. — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC (510k cleared)

    Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoThermo Fisher Scientific — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

    full page →fda device 510k ↗
    ›Oct 1, 2024device 510k660d agoSprintray, Inc. — Crown HT (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k659d agoLiaoning Upcera Co., Ltd. — Ceramic Etchant (HF-5 and HF-9) (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k659d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Versana Premier; Versana Premier Lotus; LOGIQ F (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k659d agoTherapixel — MammoScreen BD (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k659d agoLuminex Molecular Diagnostics, Inc. — NxTAG® Respiratory Pathogen Panel (510k cleared)Insight Molecular Diagnostics Inc.

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k659d agoArthrex, Inc. — Arthrex Virtual Implant Positioning (VIP) System Software (510k cleared)

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

    full page →fda device 510k ↗
    ›Oct 2, 2024device 510k659d agoMomentis Surgical , Ltd. — Anovo Surgical System (model 6N) (510k cleared)

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

    full page →fda device 510k ↗
    $RMD220.38+5.13%
    $UBXG
    $MOBI
    $PRCT
    $IMDX
    $TMO447.81+1.31%