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"
121–144 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 06, 2023
Savvy Surgical Mask - Level 3
K230383 · FXX
Alg Health, LLC
General Hospital · 21d
Cleared Mar 03, 2023
Electronic Sphygmomanometers
K222394 · DXN
Qingdao Yasee Medical Device Co., Ltd.
Cardiovascular · 207d
Cleared Feb 28, 2023
SurBlate Ablation System
K223272 · NEY
Mima-Pro Scientific, Inc.
General & Plastic Surgery · 127d
Cleared Feb 13, 2023
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select...
K230207 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Feb 13, 2023
syngo.via View&GO VA40A
K230196 · LLZ
Siemens Healthcare GmbH
Radiology · 19d
Cleared Feb 09, 2023
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With...
K223559 · LZA
Nephron Pharmaceuticals Corporation
General Hospital · 73d
Cleared Feb 02, 2023
Atomica Planner
K230012 · LLZ
Atomica Technology, Inc.
Radiology · 30d
Cleared Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
K223804 · JAK
Philips Ultrasound, LLC
Radiology · 30d
Cleared Jan 13, 2023
Nitrile Exam Gloves (Chemotherapy Drug Tested)
K223748 · LZA
Us Medical Glove Company, LLC
General Hospital · 30d
Cleared Jan 06, 2023
TECHFIT Diagnostic Models
K222577 · LLZ
Techfit Digital Surgery, Inc.
Radiology · 134d
Cleared Dec 29, 2022
CLEAR+BRILLIANT TOUCH® Laser System
K223647 · GEX
Solta Medical, Inc.
General & Plastic Surgery · 23d
Cleared Dec 09, 2022
CELLO II Balloon Guide Catheter
K223275 · QJP
Fuji Systems Corporation
Neurology · 46d
Cleared Dec 06, 2022
Premier's MultiMatch Universal Chameleon Restorative Composite
K223632 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Nov 28, 2022
pNOVUS 21 Microcatheter
K221279 · DQO
Phenox, Ltd.
Neurology · 209d
Cleared Nov 14, 2022
High Fluid-Resistant Surgical and Procedure Mask
K222749 · FXX
America?S Supply Chains
General Hospital · 63d
Cleared Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · LZA
Safesource Direct, LLC
General Hospital · 45d
Cleared Nov 04, 2022
Aquilo Sports CCT1500 System
K223164 · IRP
Aquilo Sports, LLC
Neurology · 28d
Cleared Nov 01, 2022
POSE™ Health Care Surgical Mask
K223270 · FXX
America?S Supply Chains
General Hospital · 8d
Cleared Sep 27, 2022
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound...
K222648 · IYN
Philips Ultrasound, LLC
Radiology · 26d
Cleared Sep 23, 2022
FREEPRINT crown
K222877 · EBF
Detax GmbH
Dental · 1d
Cleared Sep 21, 2022
MCB UNIT Model: V10GMCBUS
K222542 · KNS
Lamidey Noury Medical
Gastroenterology & Urology · 30d
Cleared Sep 14, 2022
LightForce Orthodontic System
K222764 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 12, 2022
Infrared Forehead Thermometer
K220084 · FLL
Qingdao Yasee Medical Device Co., Ltd.
General Hospital · 245d
Cleared Sep 02, 2022
Perfetta Moderate Medical Face Mask
K222426 · FXX
Phu Bao Group Company Limited
General Hospital · 22d