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
20017–20040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2020
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
K200483 · FBN
Boston Scientific Corporation
General & Plastic Surgery · 84d
Cleared May 21, 2020
X-Guide® Surgical Navigation System
K200662 · PLV
X-Nav Technologies, LLC
Dental · 69d
Cleared May 21, 2020
SPY Portable Handheld Imaging (SPY-PHI) System
K200737 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 59d
Cleared May 21, 2020
Photodynamic Therapy (PDT) Equipment
K200751 · GEX
Shangdong Huamei Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared May 21, 2020
NuVasive Thoracolumbar Plates
K200956 · KWQ
Nu Vasive, Incorporated
Orthopedic · 42d
Cleared May 21, 2020
NEXXT MATRIXX System
K200969 · MAX
Nexxt Spine, LLC
Orthopedic · 38d
Cleared May 21, 2020
Insignia™ Anterior Cervical Plate System
K200995 · KWQ
Alphatec Spine, Inc.
Orthopedic · 35d
Cleared May 21, 2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K201068 · KFM
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 21, 2020
Advincula Delineator Uterine Manipulator
K201086 · HEW
CooperSurgical, Inc.
Obstetrics & Gynecology · 28d
Cleared May 21, 2020
IntraMarX 3D Radiopaque Marker
K201106 · FFX
Anx Robotica Corp
Gastroenterology & Urology · 27d
Cleared May 20, 2020
LifeFlow Blood System
K191362 · FPA
410 Medical, Inc.
General Hospital · 364d
Cleared May 20, 2020
Infinity Angioplasty Balloon Catheter
K192399 · LIT
Infinity Angioplasty Balloon Company,...
Cardiovascular · 260d
Cleared May 20, 2020
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · DHR
Kamiya Biomedical Company
Immunology · 236d
Cleared May 20, 2020
Axis Spine Technologies ALIF
K200352 · OVD
Axis Spine Technologies, Ltd.
Orthopedic · 97d
Cleared May 20, 2020
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
K200860 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 49d
Cleared May 20, 2020
NuVasive® ACP System
K201078 · KWQ
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared May 19, 2020
SMOOV O10
K192016 · ITI
Alber GmbH
Physical Medicine · 295d
Cleared May 19, 2020
Reform Pedicle Screw System
K200303 · NKB
Precision Spine
Orthopedic · 103d
Cleared May 19, 2020
CUBEScan BioCon-900S
K200749 · IYO
Mcube Technology Co., Ltd.
Radiology · 57d
Cleared May 19, 2020
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
K200864 · PGY
Shenzhen Beacon Display Technology...
Radiology · 48d
Cleared May 19, 2020
TOPAZ Mobile DR System
K201124 · IZL
DRGEM Corporation
Radiology · 22d
Cleared May 18, 2020
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto...
K191906 · MAX
MiRus, LLC
Orthopedic · 307d
Cleared May 18, 2020
UF(II) Bar holder abutment
K193404 · NHA
Dio Corporation
Dental · 164d
Cleared May 18, 2020
VarseoSmile Temp
K193553 · EBG
Bego Bremer Goldschlagerei Wilh....
Dental · 150d