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Week of Jun 30, 2025

50

Jul 3, 2025device pma407d agoCook Ireland, Ltd. — Zilver® PTX® Peripheral Drug-Eluting Stent (PMA supplement)

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

full page →fda device pma ↗

Jul 3, 2025device pma407d agoCochlear Americas — Nucleus® 24 Cochlear Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

Jul 3, 2025device pma407d agoGeneoscopy, Inc. — ColoSense® (PMA supplement)

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

full page →fda device pma ↗

Jul 3, 2025device pma407d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Jul 3, 2025device pma407d agoInsightec — Exablate Model 4000 Type-1 System (PMA supplement)

Supplement type: Panel Track. Product code: POH. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Jul 3, 2025device pma407d agoMentor Corp. — MENTOR MemoryGel Enhance Breast Implants (PMA supplement)

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

full page →fda device pma ↗

Jul 3, 2025device pma407d agoCochlear Americas — Nucleus® 22 Cochlear Implant System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MCM. Advisory committee: EN. Decision: APPR

full page →fda device pma ↗

Jul 3, 2025device pma407d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

TRANSDUCER L12-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver) — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C6-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L12-5 38mm Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C8-4v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L9-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

X7-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoTandem Diabetes Care, Inc. device recall (Cls II)TANDEM DIABETES CARE INC

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) — Reason: an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

S9-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C8-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

mC7-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)Ocuvex Therapeutics Inc

C5-2 Lumify Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

X6-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-3v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L12-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

BP10-5ec Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

SCNHD LA L7-4 HDI Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L8-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

7.5MHZ Endo Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk. — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L10-4LAP Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C10-4ec Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

X5-1 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C8-4v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

VL13-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)Ocuvex Therapeutics Inc

S4-1 Lumify Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

S4-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

OMNI II TEE Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C9-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

3D9-3v Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L18-5 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

D2cwc Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoOrascoptic Surgical Acuity device recall (Cls II)

Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk. — Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

mL26-8 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

C6-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

eL18-4 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

mC12-3 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

L15-7io Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

X5-1c Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)Ocuvex Therapeutics Inc

L12-4 Lumify Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

S7-3t Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

Jul 3, 2025device recall407d agoPhilips Ultrasound, Inc device recall (Cls III)

S5-2 Transducer Probe — Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. — Status: Ongoing

full page →fda device recalls ↗

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