Calendar

Week of Nov 3, 2025

Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)Sri Devaraj Urs Academy of Higher Education and Research

Iron Deficiency Test (ferritin) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Thyroid TSH Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Herpes (HSV-1 & HSV-2) Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)Sri Devaraj Urs Academy of Higher Education and Research

Iron Deficiency Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Diabetes Test (ketones & glucose) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

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

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

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

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Allergy & Food Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Ovulation Test (5 tests) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Sensitivity Test Medium — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Men s Hormone Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

H pylori (Peptic ulcer) Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Neurotransmitters Basic — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Epstein-Barr Virus (EBV VCA & EBNA IgG) Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Fecal Occult Blood Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Women s Hormone Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)Worphmed Srl

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

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Nov 3, 2025device recall304d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Neurotransmitters XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

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

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Nov 3, 2025device recall304d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Sorbitol Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall304d 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 recall304d 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 recall304d 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 recall304d 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 recall304d 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 recall304d 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 recall304d 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 recall304d 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, 2025approval303d agoMEDROL (METHYLPREDNISOLONE) — FDA approvalMEDROL

Sponsor: PFIZER. Form: TABLET. Route: ORAL

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Nov 4, 2025approval303d agoISOFLURANE — FDA approvalSedana Medical AB

Sponsor: SHANDONG. Form: LIQUID. Route: INHALATION

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Nov 4, 2025approval303d agoMARAVIROC — FDA approvalForest Hills Partners Hong Kong Ltd

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

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Nov 4, 2025approval303d agoDEPO-MEDROL (METHYLPREDNISOLONE ACETATE) — FDA approvalMETHYLPREDNISOLONE ACETATE

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

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Nov 4, 2025approval303d agoIRBESARTAN — FDA approvalIRBESARTAN

Sponsor: MSN. Form: TABLET. Route: ORAL

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Nov 4, 2025approval303d agoPHYTONADIONE — FDA approvalPHYTONADIONE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION

full page →PHYTONADIONE →fda approvals ↗

Nov 4, 2025approval303d agoLOPROX (CICLOPIROX) — FDA approvalATLAS Molecular Pharma SL

Sponsor: EUROFARMA. Form: SUSPENSION. Route: TOPICAL

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Nov 4, 2025approval303d agoSULFASALAZINE — FDA approvalsulfasalazine DR

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →sulfasalazine DR →fda approvals ↗

Nov 4, 2025approval303d agoISTURISA (OSILODROSTAT PHOSPHATE) — FDA approvalosilodrostat phosphate

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

full page →osilodrostat phosphate →fda approvals ↗

Nov 4, 2025approval303d agoMIRABEGRON — FDA approvalmirabegron ER

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

full page →mirabegron ER →fda approvals ↗

Nov 4, 2025approval303d agoRISPERIDONE — FDA approvalAmneal Pharmaceuticals, Inc.

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

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Nov 4, 2025approval303d agoLOPROX (CICLOPIROX) — FDA approvalATLAS Molecular Pharma SL

Sponsor: EUROFARMA. Form: CREAM. Route: TOPICAL

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Nov 4, 2025approval303d agoSOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) — FDA approvalmethylprednisolone sodium succinate

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

full page →methylprednisolone sodium succinate →fda approvals ↗

Nov 4, 2025approval303d agoLINZESS (LINACLOTIDE) — FDA approvallinaclotide

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →linaclotide →fda approvals ↗

Nov 4, 2025device 510k303d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Suture Anchors (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device 510k303d 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

full page →fda device 510k ↗

Nov 4, 2025device 510k303d agoKarma Mobility Co, Ltd. — Flexx Junior (FLX-J00, FLX-J50) (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device 510k303d agoVieworks Co., Ltd. — VXvue (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device 510k303d agoMedcad — MedCAD® AccuStride System (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device 510k303d agoApplied Medical Resources Corp. — Voyant® Open Fusion Device (EB240/Open Fusion) (510k cleared)

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

full page →fda device 510k ↗

Nov 4, 2025device 510k303d agoMerit Medical Systems, Inc. — Merit Syringe (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗

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Week of Nov 3, 2025