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Week of Dec 1, 2025

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Dec 4, 2025device 510k254d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (510k cleared)Dawn Sea Therapeutics

Product code: JNL. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k254d agoSc Medica — FFX Facet Fixation System (510k cleared)

Product code: MRW. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗

Dec 4, 2025device 510k254d agoTigon Medical — Tigon Medical Knotless and Dual Javelin All-Suture Anchors (510k cleared)

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

full page →fda device 510k ↗

Dec 4, 2025device 510k254d agoZhejiang Taotao Vehicle Co., Ltd. — Mobility Scooter (T5) (510k cleared)

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

full page →fda device 510k ↗

Dec 4, 2025device 510k254d agoSpineology, Inc. — Spineology Navigation Instruments (510k cleared)

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

full page →fda device 510k ↗

Dec 4, 2025device pma254d agoBausch and Lomb, Inc., — Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses (PMA supplement)

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

full page →fda device pma ↗

Dec 4, 2025device pma254d agoPhysio-Control, Inc. — LIFEPAK® 35 Defibrillator/monitor (PMA supplement)

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

full page →fda device pma ↗

Dec 4, 2025device pma254d agoLenstec, Inc. — Softec HD; Softec I; Softec HDO; Softec HDM (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: HQL. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Dec 4, 2025device pma254d agoLenstec, Inc. — ClearView 3 (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MFK. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Dec 4, 2025device pma254d agoCordis US Corporation — S.M.A.R.T.® CONTROL® Nitinol Stent System (PMA supplement)

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

full page →fda device pma ↗

Dec 4, 2025device pma254d agoCordis US Corporation — S.M.A.R.T. and S.M.A.R.T.® CONTROL® Vascular Stent Systems (PMA supplement)

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

full page →fda device pma ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Allwell Inflation Device, for angiographic use REF: IS-30-A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Manifold Kit REF: K09-13203A — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMobius Imaging, LLC device recall (Cls II)

Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. — Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201 — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMobius Imaging, LLC device recall (Cls II)

Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. — Reason: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMerit Medical Systems, Inc. device recall (Cls II)MERIT MEDICAL SYSTEMS INC

Allwell Angioplasty Pack REF: IS-30-B1/B — Reason: Inflation device handle may detach from the syringe during procedure. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoMedtronic Inc device recall (Cls II)Medtronic plc

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090 — Reason: Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoAbiomed, Inc. device recall (Cls II)Abion Inc

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. — Reason: Device packaged in incorrect outer box carton. — Status: Ongoing

full page →fda device recalls ↗

Dec 4, 2025device recall254d agoIntuitive Surgical, Inc. device recall (Cls II)INTUITIVE SURGICAL INC

Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A — Reason: Due to probe bags that may have a compromised or incomplete sterile pouch seal. — Status: Ongoing

Dec 5, 2025approval253d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

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Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

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Dec 5, 2025approval253d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval253d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

Dec 5, 2025approval253d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

Dec 5, 2025approval253d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval253d agoETICOVO (ETANERCEPT-YKRO) — FDA approvalETICOVO

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

full page →ETICOVO →fda approvals ↗

Dec 5, 2025approval253d agoAMANTADINE HYDROCHLORIDE — FDA approvalShinkei Therapeutics LLC

Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL

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Dec 5, 2025approval253d agoACETAMINOPHEN — FDA approvalIGC Pharma, Inc.

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

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Dec 5, 2025approval253d agoARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

full page →amikacin sulfate PR →fda approvals ↗

Dec 5, 2025device 510k253d agoBlue Belt Technologies, Inc. — REAL INTELLIGENCE CORI XT (CORI XT) (510k cleared)BETA Technologies, Inc.

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

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. — Augmented Gingival Matrix (510k cleared)

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

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoManteia Technologies Co., Ltd. — ARTAssistant (510k cleared)

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

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoDornier Medtech America Inc (Dmta) — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) (510k cleared)

Product code: FAS. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoKarl Storz SE & CO. KG — KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612) (510k cleared)

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Special

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoEpic Medical Pte. , Ltd. — ProSeal Transfer Injector (421120, 421130, 421140) (510k cleared)

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

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoMediclus Co., Ltd. — Any-Core (510k cleared)

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

full page →fda device 510k ↗

Dec 5, 2025device 510k253d agoLincotek Medical — SpineLinc Anterior Cervical Implant System (510k cleared)

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

full page →fda device 510k ↗

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