Calendar

pharmadog

Week of Nov 3, 2025

Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Environmental Pollutants Profile Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Vaginal PH Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Gut Microbiome Test Medium — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT; — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)IBSA Institut Biochimique SA

Estrogen & Progesterone Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Continuous Glucose Monitor (CGM) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall286d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer, — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

Nov 3, 2025device recall286d agoGVS TM, Inc device recall (Cls II)

SQ40S Blood Transfusion Filter — Reason: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. — Status: Ongoing

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Nov 4, 2025approval285d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

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Nov 4, 2025approval285d agoISOFLURANE — FDA approvalSedana Medical AB

Sponsor: SHANDONG. Form: LIQUID. Route: INHALATION

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Nov 4, 2025approval285d agoMARAVIROC — FDA approvalForest Hills Partners Hong Kong Ltd

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

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Nov 4, 2025approval285d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

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Nov 4, 2025approval285d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: MSN. Form: TABLET. Route: ORAL

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Nov 4, 2025approval285d agoPHYTONADIONE — FDA approvalPHYTONADIONE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

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Nov 4, 2025approval285d agoLOPROX (CICLOPIROX) — FDA approvalATLAS Molecular Pharma SL

Sponsor: EUROFARMA. Form: SUSPENSION. Route: TOPICAL

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Nov 4, 2025approval285d agoSULFASALAZINE — FDA approvalsulfasalazine DR

Sponsor: RISING. Form: TABLET. Route: ORAL

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Nov 4, 2025approval285d agoISTURISA (OSILODROSTAT PHOSPHATE) — FDA approvalosilodrostat phosphate

Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL

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Nov 4, 2025approval285d agoMIRABEGRON — FDA approvalmirabegron ER

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

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Nov 4, 2025approval285d agoRISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: SOLUTION. Route: ORAL

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Nov 4, 2025approval285d agoLOPROX (CICLOPIROX) — FDA approvalATLAS Molecular Pharma SL

Sponsor: EUROFARMA. Form: CREAM. Route: TOPICAL

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Nov 4, 2025approval285d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

Sponsor: PHARMACIA AND UPJOHN. Form: INJECTABLE. Route: INJECTION

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Nov 4, 2025approval285d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

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Nov 4, 2025device 510k285d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Suture Anchors (510k cleared)

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

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Nov 4, 2025device 510k285d agoPrimed Medical Products, Inc. — PRIMED Surgical and Procedure Masks (510k cleared)UTAH MEDICAL PRODUCTS INC

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

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Nov 4, 2025device 510k285d agoKarma Mobility Co, Ltd. — Flexx Junior (FLX-J00, FLX-J50) (510k cleared)

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

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Nov 4, 2025device 510k285d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

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Nov 4, 2025device 510k285d agoMedcad — MedCAD® AccuStride System (510k cleared)

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

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Nov 4, 2025device 510k285d agoApplied Medical Resources Corp. — Voyant® Open Fusion Device (EB240/Open Fusion) (510k cleared)

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

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Nov 4, 2025device 510k285d agoMerit Medical Systems, Inc. — Merit Syringe (510k cleared)MERIT MEDICAL SYSTEMS INC

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

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Nov 4, 2025device 510k285d agoMenovex Medical Technology (Shenzhen) Co., Ltd. — Tamburo Thulium Fiber Laser System (510k cleared)NewBay Medical Technology Co Ltd

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

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Nov 4, 2025device 510k285d agoSiemens Medical Solutions USA, Inc. — Cios Select (510k cleared)

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

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Nov 4, 2025device pma285d agoQ-Med AB — Restylane® Lyft with Lidocaine (PMA supplement)Sustained Therapeutics Inc

Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

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Nov 4, 2025device pma285d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, (PMA supplement)

Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

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Nov 4, 2025device pma285d agoMedtronic Neuromodulation — nterStim Therapy System, Verify Evaluation System (PMA supplement)

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

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Nov 4, 2025device pma285d agoMedtronic Neuromodulation — InterStim Therapy System, Verify Evaluation System (PMA supplement)

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

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Nov 4, 2025device pma285d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (LVAS) (PMA supplement)

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

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Nov 4, 2025device pma285d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

Supplement type: Real-Time Process. Product code: LMG. Advisory committee: SU. Decision: APPR

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Nov 4, 2025device pma285d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: Real-Time Process. Advisory committee: NE. Decision: APPR

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Nov 4, 2025device recall285d agoDatascope Corp. device recall (Cls II)

Cardiosave Rescue. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

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Nov 4, 2025device recall285d agoDatascope Corp. device recall (Cls II)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

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Nov 5, 2025approval284d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: WATSON LABS INC. Form: TABLET. Route: ORAL

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Nov 5, 2025approval284d agoBOSENTAN — FDA approvalZydus Therapeutics Inc

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

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Nov 5, 2025approval284d agoBOSENTAN — FDA approvalJanssen-Cilag Holdings Inc (Inactive)

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

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Nov 5, 2025approval284d agoBOSENTAN — FDA approvalBOSENTAN

Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL