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

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175,820 results
15049–15072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2022
X-CUBE i8, X-CUBE i9
K213523 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 86d
Cleared Jan 28, 2022
QuikPass Catheter
K214106 · DQY
Traverse Vascular, Inc.
Cardiovascular · 30d
Cleared Jan 27, 2022
Omnipod 5 ACE Pump (Pod)
K203768 · QFG
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Omnipod 5 SmartBolus Calculator
K203772 · QRX
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
SmartAdjust technology
K203774 · QJI
Insulet Corporation
Chemistry · 400d
Cleared Jan 27, 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models),...
K210360 · GWO
Osteonic Co., Ltd.
Neurology · 353d
Cleared Jan 27, 2022
Sterile Auto-Disable Syringes with/without Needle for Single Use
K211210 · FMF
Azur Medical Company, Inc.
General Hospital · 279d
Cleared Jan 27, 2022
Intermittent Catheter (Not Finalized)
K211436 · GBM
Hollister Incorporated
Gastroenterology & Urology · 262d
Cleared Jan 27, 2022
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek...
K211589 · DPW
Remington Medical, Inc.
Cardiovascular · 248d
Cleared Jan 27, 2022
9Line
K211941 · DSA
Energetic Designs, Inc.
Cardiovascular · 218d
Cleared Jan 27, 2022
RA-T59 Wrist blood pressure monitor
K212312 · DXN
Lotusnine Medical Limited
Cardiovascular · 188d
Cleared Jan 27, 2022
Sim&Size
K212373 · PZO
Sim&Cure
Neurology · 181d
Cleared Jan 27, 2022
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay...
K213211 · DIO
Carolina Liquid Chemistries Corp.
Toxicology · 120d
Cleared Jan 27, 2022
Elevo Snoring Intervention Set
K213475 · LRK
Zelegent, Inc.
Dental · 90d
Cleared Jan 27, 2022
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight...
K213489 · HRS
Wishbone Medical, Inc.
Orthopedic · 87d
Cleared Jan 27, 2022
Fortilink with TiPlus Technology
K213493 · ODP
Paradigm Spine
Orthopedic · 87d
Cleared Jan 27, 2022
Merlin Aspiration System
K213771 · DXE
Mivi Neurovascular, Inc.
Cardiovascular · 56d
Cleared Jan 26, 2022
SternaFuse Fixation System
K202914 · HRS
Fusion Innovations, LLC
Orthopedic · 484d
Cleared Jan 26, 2022
American-Made Surgical Mask
K210101 · FXX
Armbrust, Inc.
General Hospital · 377d
Cleared Jan 26, 2022
LASSOSTAR NAV Circular Mapping Catheter
K211219 · DRF
Biosense Webster, Inc.
Cardiovascular · 278d
Cleared Jan 26, 2022
Surgical Face Mask
K212610 · FXX
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 162d
Cleared Jan 26, 2022
LightStim Elipsa
K212771 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 148d
Cleared Jan 26, 2022
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
K212868 · FAD
Rocamed Sam
Gastroenterology & Urology · 139d
Cleared Jan 26, 2022
Vitalograph Model 6000 Alpha
K212938 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 133d