FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,198 results for "regulatory technology services, llc"
313–336 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 15, 2019
FUJIFILM Sonosite Vevo MD Imaging System
K190476 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 16d
Cleared Mar 15, 2019
nextaro Transfer System, nextaro va
K183187 · LHI
Sfm Medical Devices GmbH
General Hospital · 116d
Cleared Mar 14, 2019
VASOBand Vascular Compression Device
K190318 · DXC
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Mar 14, 2019
BD Plastipak Syringe
K182589 · FMF
Becton, Dickinson and Company
General Hospital · 175d
Cleared Mar 08, 2019
Rulo Radiofrequency Lesion Probe
K190256 · GXI
Epimed International, Inc.
Neurology · 29d
Cleared Mar 08, 2019
EchoSure Diagnostic Ultrasound System
K190039 · IYO
Sonavex, Inc.
Radiology · 59d
Cleared Feb 16, 2019
RX-1 Rhythm Express Remote Cardiac Monitoring System
K183704 · DXH
Vivaquant, Inc.
Cardiovascular · 47d
Cleared Feb 14, 2019
Presero 3D Scanning System
K190074 · LLZ
Certis Health
General & Plastic Surgery · 29d
Cleared Feb 07, 2019
SonoSite SII Ultrasound System
K183235 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 79d
Cleared Jan 25, 2019
medi pneumatic compression system (pcs) – brio (Model 651)
K183631 · JOW
Medi USA, LP
Cardiovascular · 30d
Cleared Jan 04, 2019
PicoLO Nd:YAG Picosecond Laser System
K183392 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 28d
Cleared Jan 04, 2019
GlideScope BFlex Single-Use Bronchoscope System
K183256 · EOQ
Verathon Medical (Canada) Ulc
Ear, Nose, Throat · 44d
Cleared Jan 03, 2019
Clear Image Aligners
K183643 · NXC
Specialty Appliance Works, Inc.
Dental · 8d
Cleared Jan 02, 2019
Signature Orthodontic System
K183542 · NJM
Signature Orthodontics
Dental · 13d
Cleared Jan 02, 2019
3M Filtek Universal Restorative
K183476 · EBF
3M Espe Dental Products
Dental · 16d
Cleared Dec 28, 2018
COR12 ECG
K183369 · DPS
Corscience GmbH & Co.
Cardiovascular · 24d
Cleared Dec 27, 2018
Pulse 2.0, Pulse Pro 2.0
K183169 · IRP
NormaTec Industries, LP
Physical Medicine · 41d
Cleared Dec 27, 2018
Lotus III Multi-Pulsed Er: Yag Laser System
K182045 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 150d
Cleared Dec 21, 2018
Pulse Rx 2.0, Pulse Pro Rx 2.0
K183328 · JOW
NormaTec Industries, LP
Cardiovascular · 21d
Cleared Dec 20, 2018
O2 Concepts Oxlife Independence Model 301-0001
K182454 · CAW
O2 Concepts, LLC
Anesthesiology · 104d
Cleared Dec 06, 2018
IntelliSpace Radiology
K182926 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 45d
Cleared Nov 26, 2018
3M Clarity Aligners
K183159 · NXC
3M Company
Dental · 11d
Cleared Nov 09, 2018
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ...
K182857 · IYN
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Oct 31, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
K182679 · IYN
Canon Medical Systems Corporation
Radiology · 35d