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"
145–168 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 31, 2022
8ch Wrist Coil
K222325 · MOS
Invivo Corporation (Business Trade...
Radiology · 29d
Cleared Aug 23, 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K222257 · MOS
Invivo Corporation (Business Trade...
Radiology · 27d
Cleared Aug 18, 2022
iClean Viral Transport System (VTM-RT kit)
K212856 · JSM
Huachenyang (Shenzhen) Technology Co....
Microbiology · 344d
Cleared Aug 09, 2022
DenMat Glutaraldehyde Desensitizer
K222357 · KLE
Denmat Holding, LLC
Dental · 5d
Cleared Aug 09, 2022
LimFlow V-Ceiver
K222083 · MMX
LimFlow, Inc.
Cardiovascular · 25d
Cleared Jul 29, 2022
Bodyport Cardiac Scale
K211585 · DSB
Bodyport, Inc.
Cardiovascular · 431d
Cleared Jul 23, 2022
Powder-Free Nitrile Examination Glove, Non-Sterile
K221877 · LZA
Goodgloves Industries Sdn Bhd
General Hospital · 25d
Cleared Jul 14, 2022
Normatec Go
K221666 · IRP
NormaTec Industries, LP
Physical Medicine · 36d
Cleared Jul 11, 2022
Artix Ballon Guiding Sheath
K221846 · DQY
Inari Medical
Cardiovascular · 17d
Cleared Jul 07, 2022
medi pneumatic compression system (pcs)-genius (Model 652)
K221654 · JOW
Medi USA, LP
Cardiovascular · 30d
Cleared Jun 23, 2022
Axial3D Cloud Segmentation Service
K221511 · LLZ
Axial Medical Printing Limited
Radiology · 30d
Cleared Jun 14, 2022
ACUSON Sequoia Diagnostic Ultrasound System
K221500 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 13, 2022
3M Filtek Supreme Flowable Restorative
K221695 · EBF
3M Company Espe Dental Products
Dental · 3d
Cleared Jun 07, 2022
WHILL Model F
K221438 · ITI
Whill, Inc.
Physical Medicine · 21d
Cleared May 31, 2022
Liverty™ TIPS Access Set
K221440 · DYB
Bard Peripheral Vascular, Inc.
Cardiovascular · 14d
Cleared May 20, 2022
syngo Dynamics (Version VA40E)
K220832 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 59d
Cleared May 19, 2022
Procedure Mask with Ear Loops and Surgical Mask with Ties
K221134 · FXX
Safesource Direct, LLC
General Hospital · 30d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044 · DRA
Acutus Medical, Inc.
Cardiovascular · 27d
Cleared Apr 27, 2022
Strados Remote Electronic Stethoscope Platform (RESP)
K220893 · DSH
Strados Labs, Inc.
Anesthesiology · 30d
Cleared Apr 14, 2022
TeleScan
K220767 · LLZ
Bb Imaging
Radiology · 29d
Cleared Apr 08, 2022
ImaCor Zura Handheld ZHH-010
K220490 · IYN
Imacor, Inc.
Radiology · 45d
Cleared Mar 25, 2022
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
K220637 · FXX
Kdi Med Supply
General Hospital · 21d
Cleared Mar 24, 2022
Erchonia Zerona Z-Bed
K220519 · OLI
Erchonia Corporation
General & Plastic Surgery · 29d
Cleared Mar 24, 2022
Steth IO Spot
K220196 · DQD
Stratoscientific
Cardiovascular · 59d