Calendar

Week of Dec 1, 2025

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025recall255d agoMedical Products Laboratories, Inc. recall (Cls II)Revalesio Corp

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01 — Reason: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis — Status: Ongoing

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Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8 — Reason: CGMP Deviations — Status: Ongoing

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Dec 3, 2025device 510k255d agoBend IT Technologies, Ltd. — Bendit17 Microcatheter (510k cleared)TAT TECHNOLOGIES LTD

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

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Dec 3, 2025device 510k255d agoVoxel Ray Solutions, LLC — GentleBeam (GB1000) (510k cleared)

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

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Dec 3, 2025device 510k255d agoCoreline Soft Co., Ltd. — AVIEW Lung Nodule CAD (510k cleared)

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

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Dec 3, 2025device 510k255d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem (510k cleared)

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

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Dec 3, 2025device 510k255d agoVitalograph , Ltd. — VitaloJAK Clinic (Model 7100) (510k cleared)

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

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Dec 3, 2025device 510k255d agoInsulet Corporation — Omnipod 5 algorithm (510k cleared)INSULET CORP

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

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Dec 3, 2025device 510k255d agoHippoclinic — HippoMind (v1.0) (510k cleared)

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

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Dec 3, 2025device 510k255d agoYadu Medical (Henan) Co., Ltd. — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (510k cleared)

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

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Dec 3, 2025device 510k255d agoCovidien, LLC — Hugo RAS System (510k cleared)

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

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Dec 3, 2025device pma255d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

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

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Dec 3, 2025device pma255d 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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Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

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Dec 3, 2025device pma255d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base 24970A (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ (PMA supplement)

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

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Dec 3, 2025device pma255d 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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Dec 3, 2025device pma255d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma255d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD (PMA supplement)

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

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Dec 3, 2025device pma255d agoMedtronic, Inc. — Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

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

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Dec 3, 2025device pma255d 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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Dec 3, 2025device pma255d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (PMA)

Product code: MTF. Advisory committee: IM. Decision: APPR

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Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (PMA supplement)

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

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Dec 3, 2025device pma255d 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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Dec 3, 2025device pma255d agoMedtronic, Inc. — Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (PMA supplement)Medtronic plc

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

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Dec 3, 2025device recall255d agoPhilips North America device recall (Cls II)

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1. — Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). — Status: Ongoing

Week of Dec 1, 2025