BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medline ReNewal

    Reg #: 3032391 · FEI: 3002299608 · Expires 2026
    View on FDA
    Products
    70
    Proprietary Names
    133
    Establishment Types
    2
    Classifications
    70

    Registration Details

    Registration Name
    Medline ReNewal
    Registration Number
    3032391
    FEI Number
    3002299608
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1500 NE Hemlock Avenue
    City
    Redmond
    State
    OR
    ZIP
    97756
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252405

    Owner / Operator

    Firm Name
    Medline ReNewal
    Operator Number
    9033518
    Address
    Three Lakes Drive, --
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    Products

    Device Name Product Code
    Knife, Surgical EMF
    Catheter, Recording, Electrode, Reprocessed NLH
    Tourniquet, Pneumatic KCY
    Passer HWQ
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Burr, Orthopedic HTT
    Instrument, Manual, Surgical, General Use MDM
    Arthroscope HRX
    Tap, Bone HWX
    Snare, Surgical GAE
    Reamer HTO
    Rasp, Surgical, General & Plastic Surgery GAC
    Forceps, General & Plastic Surgery GEN
    Forceps, Biopsy, Electric, Reprocessed NLU
    Oximeter, Reprocessed NLF
    Oximeter DQA
    Saw, Powered, And Accessories HAB
    Guide, Surgical, Instrument FZX
    Laparoscope, General & Plastic Surgery, Reprocessed NLM
    Component, Traction, Invasive JEC
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Motor, Surgical Instrument, Pneumatic Powered GET
    Laryngoscope, Rigid CCW
    Device, Transfer, Patient, Manual FMR
    Reprocessed Catheter Introducer PNE
    Rasp HTR
    Single-Use Reprocessed Ultrasonic Surgical Instruments NLQ
    Cannula, Sinus KAM
    Accessories, Arthroscopic NBH
    Cable, Electrode IKD
    Orthopedic Manual Surgical Instrument LXH
    Trap, Sterile Specimen BYZ
    Retention Device, Suture KGS
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
    Forceps, Biopsy, Non-Electric, Reprocessed NON
    Motor, Surgical Instrument, Ac-Powered GEY
    Bur, Ear, Nose And Throat EQJ
    Blade, Scalpel GES
    Guide, Needle, Surgical GDF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Instrument, Ligature Passing And Knot Tying HCF
    Stapler, Surgical GAG
    Countersink HWW
    Apparatus, Traction, Non-Powered HST
    Staple, Removable (Skin) GDT
    Laparoscope, General & Plastic Surgery GCJ
    Cutter, Surgical FZT
    Chisel (Osteotome) KDG
    Scissors, General, Surgical LRW
    Curette, Adenoid KBJ
    Microdebrider, Ent, High Speed, Single Use, Reprocessed NLY
    Needle, Phacoemulsification, Reprocessed NKX
    Operating Room Accessories Table Tray FWZ
    Component, Traction, Non-Invasive KQZ
    Bit, Surgical GFG
    Blade, Saw, Surgical, Cardiovascular DWH
    Shield, Eye, Radiological IWS
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Sleeve, Limb, Compressible JOW
    Instrument, Ultrasonic Surgical LFL
    Scalpel, One-Piece GDX
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Bit, Drill HTW
    Knife, Orthopedic HTS
    Device, Patient Transfer, Powered FRZ
    Bur, Surgical, General & Plastic Surgery GFF
    Retractor GAD
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter MEDISISS ExpressAire Tourniquet Cuff, Single Port, Standard Arm, w/PLC, No Stockinette (Yellow) 24" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Purple) 12" x 2" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/LL, (Purple) 34" x 4" MEDISISS ExpressAire Tourniquet Cuff, Single Port, Standard Leg, w/LL, No Stockinette, (Yellow) 24" MEDISISS Tourniquet Cuff, SPDB, w/Luer Lock (Green) 24" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (Red) 18" MEDISISS ExpressAire Touniquet Cuff, Single Port, Long Leg, w/LL, No Stockinette, (Blue) 34" MEDISISS ExpressAire Tourniquet Cuff, Dual Port, Standard Leg, w/LL, No Stockinette, (Plum) 12" MEDISISS Tourniquet Cuff, SPSB. w/Luer Lock (Purple) 42" MEDISISS Tourniquet Cuff, SPSB, w/PLC (Brown) 34" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/LL, (Navy Blue) 44" x 4" MEDISISS Tourniquet Cuff, DPDB, w/PLC (Green) 24" MEDISISS Tourniquet Cuff, DPSB, w/PLC (Brown) 34" MEDISISS Tourniquet Cuff, DPSB, w/PLC, Protective Sleeve (Blue) 30" MEDISISS ExpressAire Tourniquet Cuff, Single Port, Medium Leg, w/PLC, No stockinette (White) 30" MEDISISS Tourniquet Cuff, SPSB, w/PLC (Green) 24" MEDISISS Expressaire Tourniquet Cuff, Dual Port, Child, w/PLC, No Stockinette, (Plum) 12" x 3.5" MEDISISS Color Cuff Cylindrical Tourniquet, SPDB, w/PLC, (Royal Blue) 18" x 5.5" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Royal Blue) 30" x 4" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (Purple) 42" MEDISISS COLOR CUFF Cylindrical Tourniquet, DPSB, w/PLC, (Navy Blue) 44" x 4" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (Red) 18" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (Brown) 34" MEDISISS STaR Sleeve, Velcro, Shoulder Traction and Rotation Sleeve MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (Purple) 42" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (Green) 24" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Red) 18" X 4" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Navy Blue) 44" x 4" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical (Purple) 42" MEDISISS ExpressAire Tourniquet Cuff, Single Port, Standard Arm, w/PLC, No Stockinette, (Red) 18" MEDISISS Tourniquet Cuff, DPDB, ATS Cylindrical (Red) 18" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/LL, (Red) 18" x 4" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Red) 18" X 3" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (Light Blue) 12" MEDISISS ExpressAire Tourniquet Cuff, Dual Port, Standard Leg, w/PLC, No stockinette (Yellow) 24" MEDISISS Tourniquet Cuff, DPSB, w/PLC (Red) 18" MEDISISS Tourniquet Cuff, DPSB, w/PLC (Green) 24" MEDISISS ExpressAire Tourniquet Cuff, Single Port Standard Arm, w/PLC, No Stockinette, (Blue) 34" MEDISISS Tourniquet Cuff, DPSB, w/PLC (Lt. Blue) 12" MEDISISS STaR Sleeve, Shoulder Traction and Rotation Device, (Blue) MEDISISS Tourniquet Cuff, SPSB, w/Luer Lock (Green) 24" MEDISISS Tourniquet Cuff, SPSB, w/PLC (Red) 18" MEDISISS ExpressAire Tourniquet Cuff, Single Port, Standard Arm, w/LL, No Stockinette, (Red) 18" MEDISISS Tourniquet Cuff, SPSB, w/PLC (Purple) 42" MEDISISS Tourniquet Cuff, SPSB, w/Luer Lock (Brown) 34" MEDISISS Tourniquet Cuff, DPDB, w/PLC (Red) 18" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Royal Blue) 30" x 4" MEDISISS COLOR CUFF Cylindrical Tourniquet, DPSB, w/LL, (Navy Blue) 44" x 4" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Purple) 12" x 3" MEDISISS Tourniquet Cuff, SPSB, w/PLC w/Protective Sleeve (Lt. Blue) 12" Medline ReNewal Tourniquet Cuff Medline ReNewal ExpressAire Tourniquet Cuff MEDISISS Tourniquet Cuff, SPSB, w/Luer Lock (White) 8" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (Blue) 30" MEDISISS Tourniquet Cuff, SPSB, w/PLC (Lt. Blue) 12" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Purple) 34" X 4" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (Navy Blue) 30" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (Green) 24" MEDISISS Tourniquet Cuff, Standard Leg, Single Port, w/o Stockinette, (Yellow) 24" MEDISISS Tourniquet Cuff, SPSB, W PLC (Purple) 42" MEDISISS Tourniquet Cuff, Super Cuff, Single Port, w/o Stockinette, (Green) 44" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical (White) 8" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical (Red) 18" MEDISISS Tourniquet Cuff, DPDB, w/Luer Lock (Green) 24" MEDISISS Expressaire Tourniquet Cuff, Dual Port, Child Long, w/PLC, No Stockinette, (Gray) 15" x 4" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Yellow) 24" x 4" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical Cuff (Brown) 34" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical (Green) 24" MEDISISS ExpressAire Tourniquet Cuff, Dual Port, Standard Leg, w/LL, No Stockinette, (Green) 44" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Yellow) 24" x 4" MEDISISS Tourniquet Cuff, Long Leg, Single Port, w/o Stockinette, (Blue) 34" MEDISISS Tourniquet Cuff, SPSB, w/PLC (White) 8" MEDISISS Expressaire Tourniquet Cuff, Dual Port, Standard Arm, w/PLC, No Stockinette, (Red) 18" x 4" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Red) 18" x 3" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical w/Tubing and Hose, (Green) 24" MEDISISS Tourniquet Cuff, DPDB, w/PLC (Lt. Blue) 12" MEDISISS Tourniquet Cuff, DPDB, ATS Cylindrical (Green) 24" MEDISISS Tourniquet Cuff, DPSB, w/PLC (Navy Blue) 30" MEDISISS Tourniquet Cuff, SPSB, w/Luer Lock (Lt. Blue) 12" MEDISISS Tourniquet Cuff, SPDB, w/Luer Lock (Red) 18" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/LL, (Yellow) 24" x 4" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/LL, (Royal Blue) 30" x 4" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical w/Tubing, (Green) 24" MEDISISS ExpressAire Tourniquet Cuff, Single Port, Medium Leg, w/LL, No Stockinette, (White) 30" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, Pink 15" x 2.25" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Green) 12" x 2" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (Brown) 34" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (White) 8" MEDISISS ExpressAire Tourniquet Cuff, Dual Port, Standard Leg, W/PLC, No stockinette (Blue) 34" MEDISISS Tourniquet Cuff, DPSB, w/Luer Lock (Lt. Blue) 12" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical (Navy Blue) 30" MEDISISS Tourniquet Cuff, SPSB, ATS Cylindrical (Blue) 12" MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Green) 12" x 3.5" MEDISISS ExpressAire Tourniquet Cuff, Single Port, Extra Long Leg, w/LL, No Stockinette, (Green) 44" MEDISISS Tourniquet Cuff, SPSB, w/Luer Lock (Red) 18" MEDISISS Color Cuff Cylindrical Tourniquet, SPDB, w/PLC, (Red) 18" x 5.5" MEDISISS Tourniquet Cuff, SPDB, w/PLC (Red) 18" MEDISISS Tourniquet Cuff, DPDB, w/Luer Lock (Red) 18 " MEDISISS Color Cuff II, Cylindrical Tourniquet, SPDB, Bier Block, w/PLC, (Navy Blue) 24" x 5.5" MEDISISS Tourniquet Cuff, DPSB, ATS Cylindrical (White) 8" MEDISISS Tourniquet Cuff, DPSB, w/PLC (Purple) 42" MEDISISS Tourniquet Cuff, DPSB, w/PLC (White) 8" MEDISISS Tourniquet Cuff, DPDB, w/Luer Lock, (Light Blue) 12" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Purple) 34" x 4" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC, (Red) 18" x 4" MEDISISS Tourniquet Cuff, SPSB, w/PLC (Navy Blue) 30" MEDISISS Color Cuff Cylindrical Tourniquet, SPSB, w/PLC (Green) 12" x 3.5" MEDISISS Tourniquet Cuff, SPSB, w/Luer Lock (Navy Blue) 30" Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices Medline ReNewal Reprocessed Arthroscopic Shavers and Burrs MEDISISS Cannulated Tap for 4mm Cannulated Screws 147mm MEDISISS 3.5mm Tap (Gold) MEDISISS A.O. Synthes Style Tap, Titanium Nitride Coated, Replaces 311.32 MEDISISS Tap, Quick Connect, Long MEDISISS Tap, Quick Connect Short MEDISISS ECT Quick-Connect Tap MEDISISS ECT Quick-Connect Tap, Fine Thread, (Gold) MEDISISS OATS Set, Osteochondral Autograft Transfer System, (Blue/White) MEDISISS Tap, Quick Connect, For 4mm Screws Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors Medline ReNewal Reprocessed Sage Products LLC Air Transfer Mattress Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors Medline ReNewal Reprocessed ECG leads Medline ReNewal Ablation Wands Medline ReNewal Reprocessed Stryker SERFAS Energy Probes Medline ReNewal Reprocessed Synthes External Fixation Devices Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable Medline ReNewal Ultrasonic Reprocessed Instrument Medline ReNewal Reprocessed Harmonic ACE+7 Shears Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set Medline ReNewal Reprocessed HoverMatt® Air Transfer Mattress

    Establishment Types

    Reprocess Single-Use Device Repack or Relabel Medical Device