Regulatory Technology Services (RTS) is the #1 FDA Accredited Third Party 510k Review Organization (3PRO to perform 510(k) reviews under the FDA’s Accredited Persons Program (3P510k).
Since our inception, RTS engineers, scientists, and clinicians have reviewed over 1,500 submissions averaging 10-14 days from receipt of submission to completion of substantive review.
Recent Clearances - Updated as of November 5, 2022
https://www.rts3pro.com/index.html
Philips Ultrasound LLC | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
system, imaging, pulsed doppler, ultrasonic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222648
DETAX GmbH | FREEPRINT crown
material, tooth shade, resin
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222877
Lamidey Noury Medical | MCB UNIT Model: V10GMCBUS
unit, electrosurgical, endoscopic (with or without accessories)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222542
LightForce Orthodontics | LightForce Orthodontic System
bracket, ceramic, orthodontic
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222764
Shanghai Kindly Medical Instruments Co., Ltd | INT Introducer Set
introducer, catheter
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222647
Qingdao Yasee Medical Device Co., Ltd. | Infrared Forehead Thermometer
thermometer, electronic, clinical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220084
Phu Bao Group Company Limited | Perfetta Moderate Medical Face Mask
mask, surgical
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222426
Invivo Corporation (Business Trade Name: Philips) | 8ch Wrist Coil
coil, magnetic resonance, specialty
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222325
Company Details
- Employees
- 7
- Founded
- -
- Address
- 1000 Westgate Dr,
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Keywords
- | LinkedIn.
- HQ
- Saint Paul, Minnesota
Regulatory Technology Services Questions
Regulatory Technology Services's website is https://www.rts3pro.com/index.html
Regulatory Technology Services's LinkedIn profile is https://www.linkedin.com/company/regulatory-technology-services
Regulatory Technology Services has
7 employees.
View email and phone details for 7
employees at Regulatory Technology Services.
Regulatory Technology Services's industry is
Medical Equipment Manufacturing
Regulatory Technology Services's top competitors are
Regulatory Affairs Professionals Society (Raps),
Tprg - Third Party Review Group,
Gqrs,
Integrity Quality Consulting, Llc,
Iteam Forward,
Qrx Partners,
Onq Management Consulting Llc,
Chiltern,
Beanstock Consulting,
G2 Consulting Services, Inc.
Regulatory Technology Services's categories are Medical Equipment Manufacturing
Regulatory Technology Services's founding year is 2003
