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Week of Mar 30, 2026

50

Mar 31, 2026approval142d agoMESALAMINE — FDA approvalTakeda Pharmaceuticals USA Inc

Sponsor: KLM LABS PVT. Form: ENEMA. Route: RECTAL

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Mar 31, 2026device 510k142d 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 510k142d agoMediott, Inc. — RW-1 (510k cleared)

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

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Mar 31, 2026device 510k142d 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 510k142d 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 510k142d 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 510k142d 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 pma142d 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 pma142d 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 pma142d 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 event142d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

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Mar 31, 2026device adverse event142d agoINSET — Injury event

Appropriate Term/Code Not Available

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Mar 31, 2026device adverse event142d agoGLIDEWELL HT IMPLANT Ø3.5 X 10 MM — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event142d agoQUICK SET — Injury event

Leak/Splash; Loose or Intermittent Connection

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Mar 31, 2026device adverse event142d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Patient-Device Incompatibility

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Mar 31, 2026device adverse event142d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Malposition of Device

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Mar 31, 2026device adverse event142d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

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Mar 31, 2026device adverse event142d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event142d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

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Mar 31, 2026device adverse event142d agoPRIMETAPER EV Ø3.6 X 9MM OS — Injury event

Loss of Osseointegration

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Mar 31, 2026device adverse event142d agoINGEVITY+ — Injury eventBOSTON SCIENTIFIC CORP

Insufficient Information

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Mar 31, 2026device adverse event142d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate; Migration

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Mar 31, 2026device adverse event142d agoASTRATECH IMPL EV 3.0S 11MM OS — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event142d agoAMS 700? CXR TENACIO? PUMP — Injury eventBOSTON SCIENTIFIC CORP

Collapse; Fluid/Blood Leak

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Mar 31, 2026device adverse event142d agoEMBLEM? MRI S-ICD — Injury eventBOSTON SCIENTIFIC CORP

Insufficient Information

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Mar 31, 2026device adverse event142d agoPROPONENT MRI EL DR — Injury eventBOSTON SCIENTIFIC CORP

Incorrect, Inadequate or Imprecise Result or Readings

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Mar 31, 2026device adverse event142d agoGORE® DRYSEAL FLEX INTRODUCER SHEATH — Injury event

Patient Device Interaction Problem

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Mar 31, 2026device adverse event142d agoFREESTYLE LIBRE 3 PLUS — Injury eventTANDEM DIABETES CARE INC

Low Readings

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Mar 31, 2026device adverse event142d agoEDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE — Injury eventEdwards Lifesciences Corp

Insufficient Information

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Mar 31, 2026device adverse event142d agoDJO SURGICAL — Injury eventEncore Medical, Inc.

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event142d agoDJO SURGICAL — Injury eventEncore Medical, Inc.

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event142d agoOSSEOSPEED TX 4.5 - 9 MM — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event142d agoMITRIS RESILIA MITRAL VALVE — Injury eventEdwards Lifesciences Corp

Patient Device Interaction Problem

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Mar 31, 2026device adverse event142d agoVARIPULSE¿ BI-DIRECTIONAL CATHETER — Injury event

Patient Device Interaction Problem

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Mar 31, 2026device adverse event142d agoINGEVITY?+ — Injury eventBOSTON SCIENTIFIC CORP

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event142d agoDEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM — Injury eventDEXCOM INC

High Readings

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Mar 31, 2026device adverse event142d agoUNKNOWN TORNIER AEQUALIS REV II GLENOID IMPLANT — Injury event

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event142d agoPRECISION SPECTRA ? — Injury event

Charging Problem

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Mar 31, 2026device adverse event142d agoINSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT — Injury event

Material Rupture

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Mar 31, 2026device adverse event142d agoFREESTYLE LIBRE 3 — Injury event

Low Readings

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Mar 31, 2026device adverse event142d agoSIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML — Injury event

Osseointegration Problem

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Mar 31, 2026device adverse event142d agoANK C/X IMPL A6,6/D3,5/L6,6 — Injury event

Loss of Osseointegration

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Mar 31, 2026device adverse event142d agoINSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT — Injury event

Material Rupture

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Mar 31, 2026device adverse event142d agoDEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM — Injury eventDEXCOM INC

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event142d agoOCTRODE LEAD KIT, 60CM LENGTH — Injury event

Migration

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Mar 31, 2026device adverse event142d agoPHENOM CATHETER — Injury eventMiNK Therapeutics, Inc.

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event142d agoPRODIGY MRI IPG, 16CH, RECHARGEABLE — Injury event

Improper or Incorrect Procedure or Method

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Mar 31, 2026device adverse event142d agoINSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT — Injury event

Device Appears to Trigger Rejection

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Mar 31, 2026device adverse event142d agoLEGACY3 SBM IMPLANT 3.7DX10L 3.5MMD PLAT — Injury event

Positioning Failure; Insufficient Information

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Mar 31, 2026device adverse event142d agoANK C/X IMPL A8/D3.5/L8 — Injury event

Loss of Osseointegration

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