Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010034260

FEI Number

3010034260

Entity Name

SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.

City/State/Country

Santa Rosa, CA, US

Establishment Address

3250 BRICKWAY BLVD, Santa Rosa, CA 95403, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SCIENTIFIC MOLDING CORPORATION LTD (Owner Number: 9057460)

Owner / Operator Contact Address

330 SMC DRIVE, --, Somerset, WI 54025, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INTRACEPT RF PROBE Artemis Neuro Evacuation Device BAROguard KidneyVault Disposable pullback sled for Motordrive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2023-08-01
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2019-04-12
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2017-10-20
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2025-09-10
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2018-08-02
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2025-09-10
KDN	System, Perfusion, Kidney	Gastroenterology, Urology	Class 2	876.5880	2023-05-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-08-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SCIENTIFIC MOLDING CORPORATION LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005910889	SCIENTIFIC MOLDING CORPORATION, LTD. DBA SMC LTD.	Amery, WI, US
1225580	SMC Ltd.	Devens, MA, US
3006467300	SMC Medical Manufacturing Private Limited	BANGALORE Karnataka, IN
3009327445	SMC Costa Rica Division S.R.L.	El Coyol Alajuela, CR
3000143502	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Somerset, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
K013575	Organ Recovery Systems, Inc.	KPS-I, THE KIDNEY PERFUSION SOLUTION	2002-01-25
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

Similar Registrations

Registration Number	Establishment Name	Location
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3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
9680425	Avent S. de R.L. de C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010034260. Last updated year: 2026. Please use registration number 3010034260 when referencing this establishment in official correspondence.