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Week of Apr 6, 2026

50

04/10/2026recall123d agoVital Nutrient recall: Dietary Supplements

Aller-C Dietary Supplement

full page →fda recalls ↗

Apr 10, 2026approval123d agoCONCERTA (METHYLPHENIDATE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval123d agoLOSARTAN POTASSIUM — FDA approvalLOSARTAN POTASSIUM

Sponsor: MICRO LABS. Form: TABLET. Route: ORAL

full page →LOSARTAN POTASSIUM →fda approvals ↗

Apr 10, 2026approval123d agoMETHYLPREDNISOLONE — FDA approvalPFIZER INC

Sponsor: TIANJIN TIANYAO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval123d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval123d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval123d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval123d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

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

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval123d agoMETHYLPREDNISOLONE ACETATE — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION

full page →METHYLPREDNISOLONE ACETATE →fda approvals ↗

Apr 10, 2026approval123d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 10, 2026approval123d agoLIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% (LIDOCAINE HYDROCHLORIDE) — FDA approvalLaryng-O-Jet

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Laryng-O-Jet →fda approvals ↗

Apr 10, 2026approval123d agoDILTIAZEM HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Apr 10, 2026approval123d agoMETHYLPREDNISOLONE — FDA approvalMEDROL

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →MEDROL →fda approvals ↗

Apr 10, 2026approval123d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: STRIDES PHARMA INTL. Form: FOR SUSPENSION. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Apr 10, 2026device 510k123d agoAscblue Corporation — Ascblue (8010) (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoDk Medical Systems Co., Ltd. — AeroDR TX c02 (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoPlasma Surgical, Inc. — ARION ARC System (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoSophysa — Pressio 3 Multi-parameter Neuromonitoring System (510k cleared)

Product code: GWM. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d ago1987 Media Limited — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (510k cleared)

Product code: OBR. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoOkami Medical, Inc. — LOBO Vascular Occlusion System (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d ago3Shape TRIOS A/S — TRIOS Dx (R1) (510k cleared)

Product code: SHQ. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoActis Medical Pty., Ltd. — SMART Osteotomy System (510k cleared)Atticus Medical Pty Ltd

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoRelu BV — Relu Cloud (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoUniversity of Utah, Department of Orthopaedics — CoAptix S System (510k cleared)University of Utah

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoAitewan Biomedical Technology, Inc. — DeepBT Detector-Plus (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoShanghai Draeger Medical Instrument Co., Ltd. — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoShenB Co., Ltd. — Diacore (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoBecton, Dickinson and Company — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube (510k cleared)BECTON DICKINSON & CO

Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoOverjet, Inc. — Overjet Iris Intelligent Imaging System (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoShaeferh, LLC — ShaeferH (510k cleared)

Product code: LRK. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoBecton, Dickinson and Company — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder (510k cleared)BECTON DICKINSON & CO

Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoCovidien (Part of Medtronic) — Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoSiemens Healthcare GmbH — syngo Dynamics (VA41F) (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Teleport Glide Microcatheter (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoMedela, LLC — Freestyle Mini Hands-free (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoCequr SA — CeQur Simplicity On-Demand Insulin Delivery System (510k cleared)Shanghai Jiao Tong University

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoCognifisense, Inc. — VRNT (510k cleared)

Product code: QRA. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoSiemens Healthcare GmbH — AI-Rad Companion Organs RT (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoProtaryx Medical, Inc. — Protaryx Transseptal Puncture Device (PTX2-001) (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoEximo Medical — Auryon Atherectomy System (510k cleared)

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

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoBelport Company, Inc., Gingi-Pak — Porcelain Etch Gel (510k cleared)

Product code: KLE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device 510k123d agoRadiometer Medicals Aps — ABL90 FLEX PLUS System, safeCLINITUBES (510k cleared)

Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗

Apr 10, 2026device pma123d agoBoston Scientific — Lead Port Plug Model 6996 (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Apr 10, 2026device pma123d agoZoll Circulation, Inc. — TherOx Downstream System (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: MWG. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma123d agoAutoGenomics, Inc. — AvertD and AvertD Buccal Sample Collection Kit (PMA supplement)NEOGENOMICS INC

Supplement type: Real-Time Process. Product code: QZH. Advisory committee: TX. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma123d agoBoston Scientific Corp — Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Apr 10, 2026device pma123d agoBoston Scientific — Wrench Kit Model 6501 (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Apr 10, 2026device pma123d agoBoston Scientific — Vein Pick Model 6541 (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Apr 10, 2026device pma123d agoBoston Scientific Corporation — TheraSphere (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track No User Fee. Product code: NAW. Advisory committee: RA. Decision: APPR

full page →fda device pma ↗

Apr 10, 2026device pma123d agoDePuy Orthopaedics, Inc. — Ceramax Ceramic Hip System (PMA supplement)

Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

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