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Week of Oct 27, 2025

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Oct 27, 2025device 510k294d agoTouchbeauty Beauty & Health ( Shenzhen ) Co., Ltd — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) (510k cleared)

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

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Oct 27, 2025device 510k294d agoTechfit Digital Surgery, Inc. — TECHFIT Patient-Specific Cranial System (510k cleared)

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

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Oct 27, 2025device 510k294d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (HL-3058, F5112) (510k cleared)

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

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Oct 27, 2025device 510k294d agoViet Phu Trade and Import Export Co., Ltd. — Disposable Vinyl Examination Gloves (510k cleared)

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

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Oct 27, 2025device 510k294d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

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

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Oct 27, 2025device 510k294d agoFimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Electric Breast Pump (HL-3060, F5113) (510k cleared)

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

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Oct 27, 2025device pma294d agoW. L. Gore & Associates, Inc. — GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MIR. Advisory committee: CV. Decision: APPR

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Oct 27, 2025device pma294d agoBoston Scientific Corp — ROTAPRO Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Oct 27, 2025device pma294d agoEdwards Lifesciences, LLC — TRIFORMIS RESILIA Tricuspid Valve (PMA supplement)Edwards Lifesciences Corp

Supplement type: Panel Track. Product code: LWR. Advisory committee: CV. Decision: APPR

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall294d agoPhilips North America device recall (Cls II)

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM — Reason: Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications. — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe. — Status: Ongoing

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Oct 27, 2025device recall294d agoNipro Medical Corporation device recall (Cls II)

Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only — Reason: Screw may loosen or fallout of Hemodialysis system — Status: Ongoing

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Oct 27, 2025device recall294d agoMedline Industries, LP device recall (Cls II)

Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗

Oct 28, 2025approval293d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

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Oct 28, 2025approval293d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

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Oct 28, 2025approval293d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

full page →lebrikizumab →fda approvals ↗

Oct 28, 2025approval293d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DEXTROAMPHETAMINE SULFATE →fda approvals ↗

Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: CHANGZHOU PHARM. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalSciegen Pharmaceuticals Inc

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

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: TARO. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoNICARDIPINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: QILU PHARM HAINAN. Form: INJECTABLE. Route: INJECTION

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Oct 28, 2025approval293d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →infliximab biosimilar →fda approvals ↗

Oct 28, 2025approval293d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 28, 2025approval293d agoTRIUMEQ PD (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET, FOR SUSPENSION. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalTICAGRELOR

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

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Oct 28, 2025approval293d agoDROSPIRENONE AND ESTRADIOL (DROSPIRENONE) — FDA approvalExeltis USA Inc

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

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Oct 28, 2025approval293d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval293d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

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Oct 28, 2025device 510k293d agoVolcano Corporation (Dba Philips Image Guided Therapy Device — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (510k cleared)

Product code: OBJ. Advisory committee: Cardiovascular. Type: Special

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Oct 28, 2025device 510k293d agoCg Medtech Co., Ltd. — UniSpace® TPLIF Cage (510k cleared)

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

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Oct 28, 2025device 510k293d agoBaylis Medical Technologies, Inc. — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch (510k cleared)Medical Care Technologies Inc.

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

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Oct 28, 2025device 510k293d agoBoston Scientific Corporation — TheraSphere 360 Y-90 Management Platform (510k cleared)BOSTON SCIENTIFIC CORP

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

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Oct 28, 2025device 510k293d agoWellell, Inc. — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr (510k cleared)

Product code: JOW. Advisory committee: Cardiovascular. Type: Special

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Oct 28, 2025device 510k293d agoBodycad Laboratories, Inc. — Fine Osteotomy (510k cleared)Barr Laboratories Inc

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

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Oct 28, 2025device 510k293d agoTyber Medical, LLC — Navigated Instruments (510k cleared)

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

full page →fda device 510k ↗

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