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calendar

82 catalysts · 39 device pma · 23 device 510k · 14 recall · 6 approval

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2026-08-24: 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: 1 catalyst2026-09-02: 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 catalysts
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  • device pma39
  • device 510k23
  • recall14
  • approval6
therapy area

no tagged catalysts yet

Week of Jun 16, 2025

32
›
Jun 18, 2025
device pma
439d ago
ABBOTT MEDICAL — Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoMedtronic, Inc. — Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoIntersect Ent. — PROPEL, PROPEL MINI and PROPEL CONTOUR (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWO. Advisory committee: EN. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoBausch & Lomb, Inc. — enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (PMA supplement)Bausch & Lomb Corp

Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: MG. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoBiotronik, Inc. — Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri (PMA supplement)

Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoAlcon Laboratories, Inc. — AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (PMA supplement)Alcon Laboratories Inc

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device pma439d agoNeomend, Inc. — PROGEL™ Pleural Air Leak Sealant (PMA supplement)

Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30

full page →fda device pma ↗
›Jun 18, 2025device 510k439d agoShenzhen Wikkon Precision Technologies Co., Ltd. — Extracorporeal Shock Wave Lithotripter (U200) (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Ureteral Stents (AF-D series) (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoSeaSpine Orthopedics Corporation — Virata Spinal Fixation System (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoAcumed, LLC — The Acumed Wrist Fixation System (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoHappy Health, Inc. — Happy Health Home Sleep Test (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoCenterPoint Systems, LLC — FlexiGo 3D Delivery Catheter (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoFisher & Paykel Healthcare Limited — F&P Nova Nasal Mask (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoCuriteva, Inc. — Curiteva Porous PEEK Standalone ALIF System (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoBard Access Systems, Inc. — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoSpineart SA — SPINEART Navigation Instrument System (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoConmed Corporation — CONMED Argo Knotless® Anchor (510k cleared)CONMED Corp

Product code: MBI. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoHMC Premedical S.p.A. — Enteral Drainage System, Enteral Medicine straw (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoBioline Dental Implant Systems, Ltd. — Bioline Dental Implant System (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoJiangxi Jiangte Electric Vehicle Co., Ltd. — Mobility Scooter (JT10) (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoEyeq, Inc. — EyeQ nanoECP (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoO&M Halyard, Inc. — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoExcite Medical of Tampa Bay, LLC — DRX9000C-SL Cervical Spinal Decompression System (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoEsaote, S.p.A. — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoShanghai Saints Sages Surgical Co., Ltd. — SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoWinner Medical Co., Ltd. — Procedure mask/Surgical mask/Face mask (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoGE Medical Systems SCS — CardIQ Suite (510k cleared)

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

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoLin-Zhi International, Inc. — LZI Fentanyl III Enzyme Immunoassay (510k cleared)LIQTECH INTERNATIONAL INC

Product code: DJG. Advisory committee: Clinical Toxicology. Type: Special

full page →fda device 510k ↗
›Jun 18, 2025device 510k439d agoPhilips Ultrasound, LLC — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (510k cleared)

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

full page →fda device 510k ↗
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$CAI
$MDT91.23+1.40%
$MDT91.23+1.40%
$LIQT
$BLCO17.15+0.12%
$CNMD32.58+1.46%