Medline ReNewal

FDA Device Registration & Listing · Redmond, OR, US · Registration 3032391

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032391
FEI Number
3002299608
Entity Name
Medline ReNewal
City/State/Country
Redmond, OR, US
Establishment Address
1500 NE Hemlock Avenue, Redmond, OR 97756, US
Establishment Type(s)
Reprocess Single-Use Device
Owner / Operator
Medline ReNewal (Owner Number: 9033518)
Owner / Operator Contact Address
Three Lakes Drive, --, Northfield, IL 60093, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2000-10-25
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2025-12-01
KCY Tourniquet, Pneumatic General, Plastic Surgery Class 1 878.5910 2001-08-28
HWQ Passer Orthopedic Class 1 888.4540 2011-12-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-08-07
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2000-10-25
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2014-12-29
HRX Arthroscope Orthopedic Class 2 888.1100 2021-08-31
HWX Tap, Bone Orthopedic Class 1 888.4540 2000-10-25
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 2000-11-01
HTO Reamer Orthopedic Class 1 888.4540 2000-10-25
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-12-29
HRX Arthroscope Orthopedic Class 2 888.1100 2001-07-10
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2000-10-25
NLU Forceps, Biopsy, Electric, Reprocessed Gastroenterology, Urology Class 2 876.4300 2003-10-20
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2019-07-22
DQA Oximeter Cardiovascular Class 2 870.2700 2019-07-22
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2015-04-23
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2014-12-31
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2016-08-19
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2017-07-11
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-07-11
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2017-07-11
GET Motor, Surgical Instrument, Pneumatic Powered General, Plastic Surgery Class 1 878.4820 2000-11-21
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2014-12-29
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2000-11-21
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2021-02-08
PNE Reprocessed Catheter Introducer Cardiovascular Class 2 870.1340 2026-01-14
DQA Oximeter Cardiovascular Class 2 870.2700 2019-03-29
NLF Oximeter, Reprocessed Cardiovascular Class 2 870.2700 2019-03-29
HTR Rasp General, Plastic Surgery Class 1 878.4800 2003-10-20
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2016-08-19
KAM Cannula, Sinus General, Plastic Surgery Class 1 878.4800 2011-06-28
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2005-04-14
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2000-10-25
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2000-10-25
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2015-09-22
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2015-10-26
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2016-08-19
NON Forceps, Biopsy, Non-Electric, Reprocessed Gastroenterology, Urology Class 1 876.1075 2005-03-02
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2016-03-30
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2017-06-29
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2017-11-07
GEY Motor, Surgical Instrument, Ac-Powered General, Plastic Surgery Class 1 878.4820 2000-11-21
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2011-06-28
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2000-11-21
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2003-10-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-11-10
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-06-24
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2024-06-24
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2014-12-29
GAG Stapler, Surgical General Hospital Class 2 878.4740 2000-10-25
HWW Countersink Orthopedic Class 1 888.4540 2014-12-29
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2009-11-05
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2014-12-29
NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments Unknown Class U N/A 2016-08-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-08-19
NLM Laparoscope, General & Plastic Surgery, Reprocessed Gastroenterology, Urology Class 2 876.1500 2016-08-19
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2000-10-25
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2014-12-29
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2000-10-25
KBJ Curette, Adenoid Ear, Nose, Throat Class 1 874.4420 2014-12-29

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline ReNewal
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150357 Sterilmed, Inc. Reprocessed Electrophysiology Diagnostic Catheters 2015-08-27
K043393 Alliance Medical Corp. REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS 2005-03-23
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

Similar Registrations

Registration Number Establishment Name Location
3009703496 DADDY D PRO Sialkot Punjab, PK
2084346 MARINA MEDICAL INSTRUMENTS, INC. Davie, FL, US
1720747 SONTEC INSTRUMENTS, INC. CENTENNIAL, CO, US
3011625373 METRO MEDICAL Sialkot Punjab, PK
2029275 Sterigenics U.S., LLC Corona, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032391. Last updated year: 2026. Please use registration number 3032391 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.