Calendar

pharmadog

Week of Mar 30, 2026

Apr 1, 2026device 510k152d agoStereotaxis, Inc. — Synchrony (510k cleared)Stereotaxis, Inc.

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

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Apr 1, 2026device 510k152d agoRetmap, Inc. — RM Electrode (RMH 25-01) (510k cleared)

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

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Apr 1, 2026device 510k152d agoApple, Inc. — Medical Imaging Calibration Feature (MICF) (510k cleared)Apple Inc.

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

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Apr 1, 2026device 510k152d agoHudi Pharma Srl — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg) (510k cleared)

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

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Apr 1, 2026device 510k152d agoShenzhen AOJ Medical Technology Co., Ltd. — Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro (510k cleared)NewBay Medical Technology Co Ltd

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

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Apr 1, 2026device 510k152d agoNvision Biomedical Technologies, Inc. — enHAnce PEEK Bunion System (510k cleared)

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

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Apr 1, 2026device 510k152d agoPrana Surgical — Prana System (510k cleared)

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

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Apr 1, 2026device 510k152d agoConvatec Limited — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (510k cleared)

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

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Apr 1, 2026device 510k152d agoShenzhen RF Tech Co., Ltd. — GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only (510k cleared)

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

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Apr 1, 2026device 510k152d agoSmart Soft Healthcare AD — CoLumbo C-Spine (510k cleared)

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

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Apr 1, 2026device 510k152d agoPoly Medicure Limited — Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (510k cleared)

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

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Apr 1, 2026device 510k152d agoOrthomod, LLC — MOD-C (510k cleared)

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

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Apr 1, 2026device pma152d agoCompanion Spine France Sas — DIAM Spinal Stabilization System (PMA supplement)

Supplement type: Real-Time Process. Product code: NQO. Advisory committee: OR. Decision: APPR

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Apr 1, 2026device pma152d agoTeoxane S.A. — RHA® Redensity, RHA® Redensity Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi, RHA®4 and RHA® Dynamic Volume (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

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Apr 1, 2026device pma152d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

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Apr 1, 2026device pma152d agoBoston Scientific Corp — PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Apr 1, 2026device pma152d agoAbbott Vascular, Inc. — Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

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Apr 1, 2026device pma152d agoBoston Scientific Corp — CONTAK CD, EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILL (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Apr 1, 2026device pma152d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

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

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Apr 1, 2026device pma152d agoPramand, LLC — SpineSeal Spine Sealant (PMA supplement)

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

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Apr 1, 2026device pma152d agoAbiomed, Inc. — Impella RP System (PMA supplement)Abion Inc

Supplement type: Special (Immediate Track). Product code: PYX. Advisory committee: CV. Decision: APPR

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Apr 1, 2026device pma152d agoGuidant Corp. — CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (PMA supplement)Guident Corp.

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

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Apr 1, 2026device pma152d agoMicroTransponder, Inc. — Vivistim® Paired VNS System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

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Apr 1, 2026device pma152d agoBoston Scientific — VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Apr 1, 2026device pma152d agoBiotronik, Inc. — PRO-Kinetic Energy Coronary Stent System (PMA supplement)

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

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Apr 1, 2026device pma152d agoBiotronik, Inc. — ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System (PMA supplement)OrphAI Therapeutics Inc

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

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Apr 1, 2026device pma152d agoInstylla, Inc. — Embrace Hydrogel Embolic System (HES) (PMA supplement)

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

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Apr 1, 2026grant152d agoSTANFORD UNIVERSITY — Cellular Responses to Environmentally Driven Replication StressStanford University

ES grant. $699,950. PI: Karlene A Cimprich

Week of Mar 30, 2026