Data / Medical devices / United States / Medline ReNewal

Medline ReNewal: FDA-registered device maker in Redmond, OR, United States, 32 510(k) clearances

Name: Medline ReNewal FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medline ReNewal is registered with the FDA (registration 3032391) in Redmond, OR, United States. It lists 70 device types. The FDA files 32 510(k) clearances under its listings, the newest dated December 19, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Medline ReNewal

FDA registration number: 3032391
FEI number: 3002299608
Address: 1500 NE Hemlock Avenue, Redmond, OR, United States, 97756
Owner or operator: Medline ReNewal (9033518)
Roles: Repackager or relabeler, Reprocessor
First device listed: August 31, 1998
Registered through: 2026
Brand names listed: MEDISISS 3.5mm Tap (Gold), MEDISISS A.O. Synthes Style Tap, Titanium Nitride Coated, Replaces 311.32, MEDISISS COLOR CUFF Cylindrical Tourniquet, DPSB, w/LL, (Navy Blue) 44" x 4", MEDISISS COLOR CUFF Cylindrical Tourniquet, DPSB, w/PLC, (Navy Blue) 44" x 4", MEDISISS Cannulated Tap for 4mm Cannulated Screws 147mm, MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Green) 12" x 3.5", MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Purple) 12" x 3", MEDISISS Color Cuff Cylindrical Tourniquet, DPSB, w/PLC, (Purple) 34" X 4" and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Reprocessor	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Reprocessor	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Reprocessor	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Reprocessor	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Reprocessor	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Reprocessor	accessdata.fda.gov
Arthroscope	HRX	2	Reprocessor	accessdata.fda.gov
Bit, Drill	HTW	1	Reprocessor	accessdata.fda.gov
Bit, Surgical	GFG	1	Reprocessor	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Reprocessor	accessdata.fda.gov
Blade, Saw, Surgical, Cardiovascular	DWH	1	Reprocessor	accessdata.fda.gov
Blade, Scalpel	GES	1	Reprocessor	accessdata.fda.gov
Bur, Ear, Nose And Throat	EQJ	1	Reprocessor	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Reprocessor	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Reprocessor	accessdata.fda.gov
Cable, Electrode	IKD	2	Reprocessor	accessdata.fda.gov
Cannula, Sinus	KAM	1	Repackager or relabeler, Reprocessor	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Reprocessor	accessdata.fda.gov
Catheter, Recording, Electrode, Reprocessed	NLH	2	Reprocessor	accessdata.fda.gov
Chisel (Osteotome)	KDG	1	Reprocessor	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Reprocessor	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Reprocessor	accessdata.fda.gov
Countersink	HWW	1	Reprocessor	accessdata.fda.gov
Curette, Adenoid	KBJ	1	Reprocessor	accessdata.fda.gov
Cutter, Surgical	FZT	1	Reprocessor	accessdata.fda.gov
Device, Patient Transfer, Powered	FRZ	2	Reprocessor	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Reprocessor	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Reprocessor	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	NUJ	2	Reprocessor	accessdata.fda.gov
Forceps, Biopsy, Electric, Reprocessed	NLU	2	Reprocessor	accessdata.fda.gov
Forceps, Biopsy, Non-Electric, Reprocessed	NON	1	Reprocessor	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Reprocessor	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Reprocessor	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Reprocessor	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Reprocessor	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Reprocessor	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Repackager or relabeler, Reprocessor	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Reprocessor	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Reprocessor	accessdata.fda.gov
Knife, Surgical	EMF	1	Reprocessor	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Reprocessor	accessdata.fda.gov
Laparoscope, General & Plastic Surgery, Reprocessed	NLM	2	Reprocessor	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Reprocessor	accessdata.fda.gov
Microdebrider, Ent, High Speed, Single Use, Reprocessed	NLY	1	Reprocessor	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Reprocessor	accessdata.fda.gov
Motor, Surgical Instrument, Pneumatic Powered	GET	1	Reprocessor	accessdata.fda.gov
Needle, Phacoemulsification, Reprocessed	NKX	2	Reprocessor	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Reprocessor	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Reprocessor	accessdata.fda.gov
Oximeter	DQA	2	Reprocessor	accessdata.fda.gov
Oximeter, Reprocessed	NLF	2	Reprocessor	accessdata.fda.gov
Passer	HWQ	1	Reprocessor	accessdata.fda.gov
Rasp	HTR	1	Reprocessor	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Reprocessor	accessdata.fda.gov
Reamer	HTO	1	Reprocessor	accessdata.fda.gov
Reprocessed Catheter Introducer	PNE	2	Reprocessor	accessdata.fda.gov
Retention Device, Suture	KGS	1	Reprocessor	accessdata.fda.gov
Retractor	GAD	1	Reprocessor	accessdata.fda.gov
Saw, Powered, And Accessories	HAB	1	Reprocessor	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Reprocessor	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Reprocessor	accessdata.fda.gov
Shield, Eye, Radiological	IWS	1	Reprocessor	accessdata.fda.gov
Single-Use Reprocessed Ultrasonic Surgical Instruments	NLQ	U	Reprocessor	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Reprocessor	accessdata.fda.gov
Snare, Surgical	GAE	1	Reprocessor	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Reprocessor	accessdata.fda.gov
Stapler, Surgical	GAG	2	Reprocessor	accessdata.fda.gov
Tap, Bone	HWX	1	Reprocessor	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Reprocessor	accessdata.fda.gov
Trap, Sterile Specimen	BYZ	2	Reprocessor	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 19, 2025	K250314	Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer	PNE	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
November 26, 2025	K252405	Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter	NLH	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
June 7, 2024	K240972	Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)	NLH	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
August 19, 2020	K193563	Medline ReNewal Reprocessed Harmonic ACE+7 Shears	NLQ	Substantially Equivalent	Surgical Instrument Service and Savings Inc.(Dba Medline Ren	accessdata.fda.gov
July 22, 2020	K201699	Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor	NLF	Substantially Equivalent	Surgical Instrument and Savings Inc (Dba Medline Renewal)	accessdata.fda.gov
July 3, 2019	K191018	Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors	NLF	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
April 15, 2019	K182828	Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer	NLM	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
March 22, 2019	K181738	Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors	DQA	Substantially Equivalent	Surgical Instrument Service and Savings Inc (Dba Medline	accessdata.fda.gov
July 27, 2018	K180580	Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices	KTT	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
November 9, 2017	K171911	Medline ReNewal Reprocessed Synthes External Fixation Systems	KTT	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
October 18, 2017	K172608	Medline ReNewal Reprocessed Stryker SERF AS Energy Probes	NUJ	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
August 3, 2017	K161358	Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds	JCX	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
June 23, 2017	K171324	Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics	NUJ	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
December 28, 2016	K163028	Medline ReNewal Reprocessed Stryker External Fixation Devices	JEC	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
May 6, 2016	K160740	Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology	NLM	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.	accessdata.fda.gov
April 5, 2016	K153258	Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars	NLM	Substantially Equivalent	Surgical Instrument Service and Savings (Dba Medline Renewal	accessdata.fda.gov
January 26, 2016	K151405	Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology	NLQ	Substantially Equivalent	Surgical Instrument Services and Savings(Dba Medline Renewal	accessdata.fda.gov
January 22, 2016	K151617	Livewire Electrophysiology Catheter	NLH	Substantially Equivalent	Surgical Instrument Service and Savings Inc.(Dba Medline Ren	accessdata.fda.gov
January 6, 2016	K152313	Medline ReNewal Reprocessed Endopath Endoscopic Instruments	NUJ	Substantially Equivalent	Surgical Instrument Services and Savings, Inc.	accessdata.fda.gov
December 16, 2015	K150524	Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology	NLQ	Substantially Equivalent	Surgical Instrument Services and Savings, Inc.	accessdata.fda.gov
January 16, 2015	K143166	Medline ReNewal Reprocessed Compression Limb Sleeves	JOW	Substantially Equivalent	Surgical Instrument Service and Savings (Dba Medline Renewal	accessdata.fda.gov
December 19, 2014	K142022	MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES	NLY	Substantially Equivalent	Medline Renewal	accessdata.fda.gov
January 7, 2014	K124033	MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS	NLQ	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
December 20, 2011	K113028	MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS	HRX	Substantially Equivalent	Medisiss	accessdata.fda.gov
February 14, 2005	K042659	MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS	NON	Substantially Equivalent	Medisiss	accessdata.fda.gov
January 23, 2004	K030598	MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS	NLQ	Substantially Equivalent	Medisiss	accessdata.fda.gov
January 24, 2003	K030179	MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES	NKX	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
December 19, 2002	K024011	SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICAL SURGICAL INSTRUMENTS AND ACCESSORIES	NLU	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
July 29, 2002	K012644	REPROCESSED TROCARS AND CANNULAS	NLM	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
June 27, 2002	K012669	REPROCESSED ELECTROSURGICAL ELECTRODES	GEI	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
June 3, 2002	K012667	REPROCESSED ARTHROSCOPIC SHAPERS	HRX	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov
May 14, 2002	K012658	REPROCESSED COMPRESSION LIMB SLEEVES	JOW	Substantially Equivalent	Surgical Instruments Service and Savings, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 3, 2013	65205	Class II	Terminated	-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet	The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.	accessdata.fda.gov

Compare with other makers

Updated December 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.