Calendar

Week of Mar 30, 2026

Mar 30, 2026device 510k140d agoImplantcast GmbH — implantcast Packaging System Update (510k cleared)

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

Mar 30, 2026device 510k140d agoCenters for Disease Control and Prevention — Francisella tularensis Real-time PCR Assay (510k cleared)Hubei Provincial Center for Disease Control and Prevention

Product code: SGA. Advisory committee: Immunology. Type: Special

full page →fda device 510k ↗

Mar 30, 2026device 510k140d agoViTAA Medical Solutions, Inc. — AiORTA - Plan v2.0 (510k cleared)

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

full page →fda device 510k ↗

Mar 30, 2026device 510k140d agoMayer Laboratories — Sagami Original 002 Polyurethane Male Condom (510k cleared)

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

full page →fda device 510k ↗

Mar 30, 2026device 510k140d agoAvatar Medical — Avatar Medical Vision (510k cleared)

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

full page →fda device 510k ↗

Mar 30, 2026device pma140d agoBiotronik, Inc. — Amvia-Solvia Pulse Generators Scan Duration Extension (PMA supplement)

Supplement type: Real-Time Process. Product code: DXY. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Mar 30, 2026device pma140d agoKaneka Pharma America Corp. — LIPOSORBER® LA-15 System (PMA supplement)

Supplement type: Real-Time Process. Product code: MMY. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Mar 30, 2026device pma140d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: QQK. Advisory committee: GU. Decision: APPR

full page →fda device pma ↗

Mar 30, 2026grant140d agoUNIVERSITY OF COLORADO DENVER — Kir2.1 channel dysfunction underlies neurovascular coupling impairment in autismUniversity of Colorado Denver

HL grant. $38,224. PI: Phinea Z Romero

full page →nih reporter ↗

Mar 30, 2026grant140d agoWEILL MEDICAL COLL OF CORNELL UNIV — Mechanisms of HBx Recognition and Epigenetic Regulation of HBV cccDNA

AI grant. $50,114. PI: Tracy Biaco

full page →nih reporter ↗

Mar 31, 2026approval139d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Mar 31, 2026approval139d agoSTAVZOR (VALPROIC ACID) — FDA approvalVALPROIC ACID

Sponsor: BIONPHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Mar 31, 2026approval139d agoVALPROATE SODIUM — FDA approvalSagent Pharmaceuticals Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROATE SODIUM — FDA approvalSagent Pharmaceuticals Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROATE SODIUM — FDA approvalSagent Pharmaceuticals Inc

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: LANNETT CO INC. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Mar 31, 2026approval139d agoMETHYLENE BLUE — FDA approvalMETHYLENE BLUE

Sponsor: ZYDUS LIFESCIENCES. Form: SOLUTION. Route: INTRAVENOUS

full page →METHYLENE BLUE →fda approvals ↗

Mar 31, 2026approval139d agoDEPAKOTE ER (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Mar 31, 2026approval139d agoDEPAKOTE (DIVALPROEX SODIUM) — FDA approvaldivalproex sodium DR

Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →divalproex sodium DR →fda approvals ↗

Mar 31, 2026approval139d agoVALPROATE SODIUM — FDA approvalVALPROATE SODIUM

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION

full page →VALPROATE SODIUM →fda approvals ↗

Mar 31, 2026approval139d agoVALPROATE SODIUM — FDA approvalVALPROATE SODIUM

Sponsor: SAGENT. Form: INJECTABLE. Route: INJECTION

full page →VALPROATE SODIUM →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: HIKMA. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalCereno Scientific AB

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

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalCereno Scientific AB

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

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalANI PHARMACEUTICALS INC

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

full page →fda approvals ↗

Mar 31, 2026approval139d agoINBRIJA (LEVODOPA) — FDA approvallevodopa

Sponsor: MERZ. Form: POWDER. Route: INHALATION

full page →levodopa →fda approvals ↗

Mar 31, 2026approval139d agoOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalSciegen Pharmaceuticals Inc

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

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROATE SODIUM — FDA approvalSagent Pharmaceuticals Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalCereno Scientific AB

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

full page →fda approvals ↗

Mar 31, 2026approval139d agoVALPROIC ACID — FDA approvalCereno Scientific AB

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

full page →fda approvals ↗

Mar 31, 2026approval139d agoMESALAMINE — FDA approvalTakeda Pharmaceuticals USA Inc

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

full page →fda approvals ↗

Mar 31, 2026device 510k139d 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 510k139d agoMediott, Inc. — RW-1 (510k cleared)

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

full page →fda device 510k ↗

Mar 31, 2026device 510k139d 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 510k139d 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 510k139d 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 510k139d 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 pma139d 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 pma139d 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 pma139d 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 event139d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoINSET — Injury event

Appropriate Term/Code Not Available

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoGLIDEWELL HT IMPLANT Ø3.5 X 10 MM — Injury event

Failure to Osseointegrate

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoQUICK SET — Injury event

Leak/Splash; Loose or Intermittent Connection

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Patient-Device Incompatibility

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoGORE® EXCLUDER® AAA ENDOPROSTHESIS — Injury event

Malposition of Device

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoSIMPLY INTERACTIVE 3.7MMD X 10MML — Injury event

Failure to Osseointegrate

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoILET BIONIC PANCREAS — Injury eventBeta Bionics, Inc.

Insufficient Information

full page →fda device maude ↗

Mar 31, 2026device adverse event139d agoPRIMETAPER EV Ø3.6 X 9MM OS — Injury event

Loss of Osseointegration

full page →fda device maude ↗

← prev

page 35 of 160

Week of Mar 30, 2026