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Week of Mar 30, 2026

50

Mar 31, 2026approval155d agoVALPROATE SODIUM — FDA approvalVALPROATE SODIUM

Sponsor: SAGENT. Form: INJECTABLE. Route: INJECTION

full page →VALPROATE SODIUM →fda approvals ↗

Mar 31, 2026approval155d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Mar 31, 2026approval155d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: HIBROW HLTHCARE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 31, 2026approval155d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: PHARMOBEDIENT CNSLTG. Form: SYRUP. Route: ORAL

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Mar 31, 2026approval155d agoVALPROIC ACID — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SYRUP. Route: ORAL

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Mar 31, 2026approval155d agoINBRIJA (LEVODOPA) — FDA approvallevodopa

Sponsor: MERZ. Form: POWDER. Route: INHALATION

full page →levodopa →fda approvals ↗

Mar 31, 2026approval155d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 31, 2026approval155d agoVALPROATE SODIUM — FDA approvalSagent Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 31, 2026approval155d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Mar 31, 2026approval155d agoVALPROIC ACID — FDA approvalCereno Scientific AB

Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

Mar 31, 2026approval155d agoMESALAMINE — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Mar 31, 2026device 510k155d 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

full page →fda device 510k ↗

Mar 31, 2026device 510k155d agoMediott, Inc. — RW-1 (510k cleared)

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

full page →fda device 510k ↗

Mar 31, 2026device 510k155d agoSanhe Meditech Co., Ltd. — Nd: YAG Laser Therapy Systems (510k cleared)

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

full page →fda device 510k ↗

Mar 31, 2026device 510k155d agoTianjin Huahong Technology Co., Ltd. — Safety lancet (XXXVII) (510k cleared)

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

full page →fda device 510k ↗

Mar 31, 2026device 510k155d agoCarbon Medical Technologies, Inc. — InjecSURE Injection System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗

Mar 31, 2026device 510k155d agoVATECH Co., Ltd. — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (510k cleared)

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

full page →fda device 510k ↗

Mar 31, 2026device pma155d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

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

full page →fda device pma ↗

Mar 31, 2026device pma155d 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

full page →fda device pma ↗

Mar 31, 2026device pma155d 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

full page →fda device pma ↗

Mar 31, 2026device adverse event155d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoINSET — Injury event

Appropriate Term/Code Not Available

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Mar 31, 2026device adverse event155d agoGLIDEWELL HT IMPLANT Ø3.5 X 10 MM — Injury event

Failure to Osseointegrate

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoQUICK SET — Injury event

Leak/Splash; Loose or Intermittent Connection

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Patient-Device Incompatibility

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Malposition of Device

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Mar 31, 2026device adverse event155d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate

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Mar 31, 2026device adverse event155d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoPRIMETAPER EV Ø3.6 X 9MM OS — Injury event

Loss of Osseointegration

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoINGEVITY+ — Injury eventBOSTON SCIENTIFIC CORP

Insufficient Information

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Mar 31, 2026device adverse event155d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate; Migration

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoASTRATECH IMPL EV 3.0S 11MM OS — Injury event

Failure to Osseointegrate

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoAMS 700? CXR TENACIO? PUMP — Injury eventBOSTON SCIENTIFIC CORP

Collapse; Fluid/Blood Leak

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoEMBLEM? MRI S-ICD — Injury eventBOSTON SCIENTIFIC CORP

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoPROPONENT MRI EL DR — Injury eventBOSTON SCIENTIFIC CORP

Incorrect, Inadequate or Imprecise Result or Readings

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoGORE® DRYSEAL FLEX INTRODUCER SHEATH — Injury event

Patient Device Interaction Problem

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoFREESTYLE LIBRE 3 PLUS — Injury eventTANDEM DIABETES CARE INC

Low Readings

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Mar 31, 2026device adverse event155d agoEDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE — Injury eventEdwards Lifesciences Corp

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoDJO SURGICAL — Injury eventEncore Medical, Inc.

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event155d agoDJO SURGICAL — Injury eventEncore Medical, Inc.

Adverse Event Without Identified Device or Use Problem

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Mar 31, 2026device adverse event155d agoOSSEOSPEED TX 4.5 - 9 MM — Injury event

Failure to Osseointegrate

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoMITRIS RESILIA MITRAL VALVE — Injury eventEdwards Lifesciences Corp

Patient Device Interaction Problem

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoVARIPULSE¿ BI-DIRECTIONAL CATHETER — Injury event

Patient Device Interaction Problem

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoINGEVITY?+ — Injury eventBOSTON SCIENTIFIC CORP

Adverse Event Without Identified Device or Use Problem

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoDEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM — Injury eventDEXCOM INC

High Readings

full page →fda device maude ↗

Mar 31, 2026device adverse event155d 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 event155d agoPRECISION SPECTRA ? — Injury event

Charging Problem

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoINSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT — Injury event

Material Rupture

full page →fda device maude ↗

Mar 31, 2026device adverse event155d agoFREESTYLE LIBRE 3 — Injury event

Low Readings

full page →fda device maude ↗

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