Calendar

Mar 31, 2026device 510k151d agoZhenjiang Assure Medical Equipment Co., Ltd. — K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)) (510k cleared)

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

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Mar 31, 2026device 510k151d agoMediott, Inc. — RW-1 (510k cleared)

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

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Mar 31, 2026device 510k151d agoSanhe Meditech Co., Ltd. — Nd: YAG Laser Therapy Systems (510k cleared)

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

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Mar 31, 2026device 510k151d agoTianjin Huahong Technology Co., Ltd. — Safety lancet (XXXVII) (510k cleared)

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

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Mar 31, 2026device 510k151d agoCarbon Medical Technologies, Inc. — InjecSURE Injection System (510k cleared)Medical Care Technologies Inc.

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

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Mar 31, 2026device 510k151d agoVATECH Co., Ltd. — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (510k cleared)

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

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Mar 31, 2026device pma151d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

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Mar 31, 2026device pma151d agoCordis US Corporation — Mynx Control Vascular Closure Device (5F, 6F/7F) (PMA supplement)

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

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Mar 31, 2026device pma151d agoTeoxane S.A. — RHA® Redensity Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi) (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: APPR

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Mar 31, 2026device adverse event151d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

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Mar 31, 2026device adverse event151d agoINSET — Injury event

Appropriate Term/Code Not Available

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Mar 31, 2026device adverse event151d agoGLIDEWELL HT IMPLANT Ø3.5 X 10 MM — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event151d agoQUICK SET — Injury event

Leak/Splash; Loose or Intermittent Connection

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Mar 31, 2026device adverse event151d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Patient-Device Incompatibility

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Mar 31, 2026device adverse event151d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Malposition of Device

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Mar 31, 2026device adverse event151d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

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Mar 31, 2026device adverse event151d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event151d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

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Mar 31, 2026device adverse event151d agoPRIMETAPER EV Ø3.6 X 9MM OS — Injury event

Loss of Osseointegration

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Mar 31, 2026device adverse event151d agoINGEVITY+ — Injury eventBOSTON SCIENTIFIC CORP

Insufficient Information

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Mar 31, 2026device adverse event151d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate; Migration

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Mar 31, 2026device adverse event151d agoASTRATECH IMPL EV 3.0S 11MM OS — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event151d agoAMS 700? CXR TENACIO? PUMP — Injury eventBOSTON SCIENTIFIC CORP

Collapse; Fluid/Blood Leak

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Mar 31, 2026device adverse event151d agoEMBLEM? MRI S-ICD — Injury eventBOSTON SCIENTIFIC CORP

Insufficient Information

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Mar 31, 2026device adverse event151d agoPROPONENT MRI EL DR — Injury eventBOSTON SCIENTIFIC CORP

Incorrect, Inadequate or Imprecise Result or Readings

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Mar 31, 2026device adverse event151d agoGORE® DRYSEAL FLEX INTRODUCER SHEATH — Injury event

Patient Device Interaction Problem

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Mar 31, 2026device adverse event151d agoFREESTYLE LIBRE 3 PLUS — Injury eventTANDEM DIABETES CARE INC

Low Readings

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Mar 31, 2026device adverse event151d agoEDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE — Injury eventEdwards Lifesciences Corp

Insufficient Information

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Mar 31, 2026device adverse event151d agoDJO SURGICAL — Injury eventEncore Medical, Inc.

Adverse Event Without Identified Device or Use Problem

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Week of Mar 30, 2026