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Week of Oct 27, 2025

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Oct 27, 2025device recall310d 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 recall310d 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 recall310d 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 recall310d 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, 2025approval309d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: MSN. Form: TABLET. Route: ORAL

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Oct 28, 2025approval309d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

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Oct 28, 2025approval309d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval309d agoENLON-PLUS (ATROPINE SULFATE) — FDA approvalAccord Healthcare Inc

Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION

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Oct 28, 2025approval309d agoEBGLYSS (LEBRIKIZUMAB-LBKZ) — FDA approvallebrikizumab

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

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Oct 28, 2025approval309d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval309d agoDEXTROAMPHETAMINE SULFATE — FDA approvalDEXTROAMPHETAMINE SULFATE

Sponsor: AZURITY. Form: TABLET. Route: ORAL

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalSciegen Pharmaceuticals Inc

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: TARO. Form: TABLET. Route: ORAL

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Oct 28, 2025approval309d agoNICARDIPINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

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

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Oct 28, 2025approval309d agoRENFLEXIS (INFLIXIMAB-ABDA) — FDA approvalinfliximab biosimilar

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

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Oct 28, 2025approval309d agoTIVICAY PD (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval309d agoTRIUMEQ PD (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalTICAGRELOR

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

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Oct 28, 2025approval309d agoDROSPIRENONE AND ESTRADIOL (DROSPIRENONE) — FDA approvalExeltis USA Inc

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

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Oct 28, 2025approval309d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

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

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Oct 28, 2025approval309d agoDOVATO (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

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

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Oct 28, 2025approval309d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

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Oct 28, 2025device 510k309d 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 510k309d agoCg Medtech Co., Ltd. — UniSpace® TPLIF Cage (510k cleared)

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

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Oct 28, 2025device 510k309d 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 510k309d 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 510k309d 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 510k309d 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 510k309d agoTyber Medical, LLC — Navigated Instruments (510k cleared)

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

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Oct 28, 2025device 510k309d agoShofu Dental Corporation — ZIRCONOMER P (510k cleared)

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

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Oct 28, 2025device 510k309d agoNeocis, Inc. — Yomi S Robotic System (510k cleared)

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

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Oct 28, 2025device pma309d agoCorcym S.r.l. — PERCEVAL SUTURELESS HEART VALVE (PMA supplement)

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

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Oct 28, 2025device pma309d agoJohnson & Johnson Surgical Vision, Inc. — Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet PRO II Dual Pack Sodium Hya (PMA supplement)JOHNSON & JOHNSON

Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30

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Oct 28, 2025device pma309d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

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Oct 28, 2025device pma309d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

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

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Oct 28, 2025device pma309d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

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Oct 28, 2025device pma309d agoABBOTT MEDICAL — Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) (PMA supplement)

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

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Oct 28, 2025device pma309d agoCorcym S.r.l. — Perceval Sutureless Heart Valve (PMA supplement)

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

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Oct 28, 2025device pma309d agoAed Battery Exchange, LLC — DBP-1400-ABE and DBP-2003- ABE (PMA supplement)

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

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Oct 28, 2025device pma309d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

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

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Oct 28, 2025device recall309d agoBaxter Healthcare Corporation device recall (Cls II)Baxter Healthcare Corp

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff. — Reason: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits. — Status: Ongoing

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Oct 28, 2025device recall309d agoIllumina, Inc. device recall (Cls II)ILLUMINA, INC.

Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205 — Reason: An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user. — Status: Ongoing

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Oct 29, 2025approval308d agoKETALAR (KETAMINE HYDROCHLORIDE) — FDA approvalPar Pharmaceutical Inc

Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION

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Oct 29, 2025approval308d agoNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (HYDROCORTISONE) — FDA approvalET-800

Sponsor: AMNEAL. Form: SOLUTION/DROPS. Route: OTIC

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