Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015151147

FEI Number

3015151147

Entity Name

BOULDER BIOMED LLC

City/State/Country

Boulder, CO, US

Establishment Address

5421 Western Avenue, Boulder, CO 80301, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Boulder BioMed dba Boulder iQ (Owner Number: 10058905)

Owner / Operator Contact Address

5421 Western Avenue, Boulder, CO 80301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MBS-Series Single-Use Short-Handled Cerebrovascular Flowprobe HxxAUL-5 Ultrafit Liner Assembly MB-Series Single-Use Cerebrovascular Flowprobe aprevo TLIF-C Articulating System (TLIF-CA) Thermally Hardened Cannulated Drill Bit (various) aprevo Anterior Lumbar Interbody Fusion, aprevo Lateral Lumbar Interbody Fusion Stellar Knee Nitinol Enhanced Device (NED) IRRAflow Suture Slicer EnlightenVue Microendoscopy System Platform Wound Dressing Extremity All Suture System Neuspera Sacral Neuromodulation (SNM) System Hubly Electric Drill Xpan Universal Trocar System Angler Steerable, Deflectable Microcatheter iMap 3d Mapping and Navigation System aprevo Anterior Lumbar Fusion Device with Interfixation Accu-joint Hemi Implant Single Sterile Fibrinet Daxor MAX 100 Syringe (MAX 100) Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade Kit SmartShot Wright-Out Hip Stem Extractor Tool Kit Wright-Out Hip Stem Extractor 5/64" T-Handle Hex Key Wright-Out Hip Stem Extractor Osteotome Handle Wright-Out Hip Stem Extractor Slide Hammer Wright-Out Hip Stem Extractor 10mm T-Handle Socket Wrench Guide Sleeve (various), Inserter Handle (various)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2024-12-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-12-09
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-04-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-10-20
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2024-12-09
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2026-02-06
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2023-10-20
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-10-20
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-10-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-16
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-09-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-09-16
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2023-10-23
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-10-23
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2025-08-29
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2023-10-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-10-23
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-10-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-10-23
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-10-20
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	Class 2	888.3730	2024-12-09
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2023-10-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-03-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-10-23

Official Correspondent

James Kasic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boulder BioMed dba Boulder iQ

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
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015151147. Last updated year: 2026. Please use registration number 3015151147 when referencing this establishment in official correspondence.