Calendar

Week of Dec 29, 2025

Dec 29, 2025device 510k244d agoCelebrace — Celebrace Software (510k cleared)

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

Dec 29, 2025device 510k244d agoCovidien, LLC — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT (510k cleared)

Product code: JOH. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Dec 29, 2025device 510k244d agoCovidien, LLC — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (510k cleared)

Product code: BZT. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗

Dec 29, 2025device pma244d agoGuardant Health, Inc. — Guardant360 CDx (PMA supplement)Guardant Health, Inc.

Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 29, 2025device recall244d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02 — Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed. — Status: Ongoing

full page →fda device recalls ↗

Dec 29, 2025device recall244d agoCerapedics, Inc. device recall (Cls II)

PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010 — Reason: Incorrect expiration date — Status: Ongoing

full page →fda device recalls ↗

Dec 29, 2025device recall244d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02 — Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed. — Status: Ongoing

full page →fda device recalls ↗

Dec 29, 2025grant244d agoDARTMOUTH-HITCHCOCK CLINIC — Improving utilization of guideline directed medical therapy and structured ex...

GM grant. $132,000. PI: Rebecca E Scully

full page →nih reporter ↗

Dec 30, 2025approval243d agoNEREUS (TRADIPITANT) — FDA approvalVanda Pharmaceuticals Inc.

Sponsor: VANDA PHARMS INC. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Dec 30, 2025approval243d agoCALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE) — FDA approvalcalcium gluconate

Sponsor: SAGENT. Form: SOLUTION. Route: INTRAVENOUS

full page →calcium gluconate →fda approvals ↗

Dec 30, 2025device 510k243d agoTruvian Health — Lipids (510k cleared)

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

full page →fda device 510k ↗

Dec 30, 2025device 510k243d agoMediso Medical Imaging Systems, Ltd. — AnyScan 3.0 NM Scanner Family (510k cleared)

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

full page →fda device 510k ↗

Dec 30, 2025device 510k243d agoTechno-Path Manufacturing , Ltd. — Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) (510k cleared)PATH

Product code: QCH. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗

Dec 30, 2025device 510k243d agoSpectrum Dynamics Medical, Ltd. — TruSPECT Processing Station (510k cleared)

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

full page →fda device 510k ↗

Dec 30, 2025device 510k243d agoArthrex, Inc. — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm (510k cleared)

Product code: MBI. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Dec 30, 2025device 510k243d agoLucas Lifecare — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (510k cleared)

Product code: FLE. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗

Dec 30, 2025device pma243d agoZOLL Medical Corporation — OneStep CPR Complete Electrode (PMA supplement)

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

full page →fda device pma ↗

Dec 30, 2025device recall243d agoIntuitive Surgical, Inc. device recall (Cls II)INTUITIVE SURGICAL INC

da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45 — Reason: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality. — Status: Ongoing

full page →fda device recalls ↗

Dec 30, 2025grant243d agoRESEARCH INST NATIONWIDE CHILDREN'S HOSP — Somatic mutations in autism spectrum disorder

MH grant. $181,224. PI: ALISA MO

full page →nih reporter ↗

Dec 31, 2025approval242d agoBUPRENORPHINE HYDROCHLORIDE — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SANALUZ. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval242d agoGLATIRAMER ACETATE — FDA approvalGLATIRAMER ACETATE

Sponsor: SCINOPHARM TAIWAN. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →GLATIRAMER ACETATE →fda approvals ↗

Dec 31, 2025approval242d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗

Dec 31, 2025approval242d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 31, 2025approval242d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PHARMOBEDIENT. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval242d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: UPSHER SMITH LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval242d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 31, 2025approval242d agoSELENIOUS ACID — FDA approvalSELENIOUS ACID

Sponsor: RK PHARMA. Form: SOLUTION. Route: INTRAVENOUS

full page →SELENIOUS ACID →fda approvals ↗

Dec 31, 2025approval242d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025approval242d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: AUROBINDO PHARMA. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Dec 31, 2025approval242d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 31, 2025approval242d agoTRAMADOL HYDROCHLORIDE — FDA approvalSenores Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 31, 2025approval242d agoATORVASTATIN CALCIUM — FDA approvalViatris Inc

Sponsor: UMEDICA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 31, 2025recall242d agoMerck Sharp & Dohme LLC recall (Cls II)Merck Sharp & Dohme LLC

Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03 — Reason: Presence of particulate matter: potential presence of metal particulates in the product. — Status: Ongoing

full page →fda recalls ↗

Dec 31, 2025recall242d agoMerck Sharp & Dohme LLC recall (Cls II)Merck Sharp & Dohme LLC

Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02. — Reason: Presence of particulate matter: potential presence of metal particulates in the product. — Status: Ongoing

full page →fda recalls ↗

Dec 31, 2025device 510k242d agoShenzhen Jiantuo Electronics Co., Ltd. — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k242d agoNeurofield, Inc. — Genesis Sleep (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k242d agoStryker Endoscopy — MOLLI 2 System (510k cleared)

Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗

Dec 31, 2025device 510k242d agoTyber Medical, LLC — Tyber Medical Trauma Screw (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device 510k242d agoArc Trauma, LLC — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) (510k cleared)

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

full page →fda device 510k ↗

Dec 31, 2025device pma242d agoRoche Molecular System, Inc. — cobas® EZH2 Mutation Test (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma242d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma242d agoRoche Molecular Systems, Inc. — cobas® KRAS Mutation Test (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWD. Advisory committee: PA. Decision: OK30

full page →fda device pma ↗

Dec 31, 2025device pma242d agoSmith & Nephew, Inc. — Ascension MCP (PMA supplement)SMITH & NEPHEW PLC

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

full page →fda device pma ↗

Dec 31, 2025device pma242d agoNeurolief , Ltd. — ProlivRx System (PMA)

Product code: JXK. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

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Week of Dec 29, 2025