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
27649–27672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2017
SOFTDISO
K170345 · IYE
Best Nomos
Radiology · 266d
Cleared Oct 27, 2017
Tyvek Sterilization Pouches with Chevron Seal
K170429 · FRG
Andersen Sterilizers, Inc.
General Hospital · 256d
Cleared Oct 27, 2017
Automatic Blood Pressure Monitor Model LD-518 & LD-537
K170466 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 254d
Cleared Oct 27, 2017
Skylife
K170585 · LBI
Neolight, LLC
General Hospital · 241d
Cleared Oct 27, 2017
C5 Diagnostic Ultrasound System
K171926 · IYN
Guangzhou Sonostar Technologies Co.,...
Radiology · 122d
Cleared Oct 27, 2017
Tubing Pack
K171979 · DWF
Medtronic, Inc.
Cardiovascular · 119d
Cleared Oct 27, 2017
Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and...
K172028 · MLY
Gebauer Company
Physical Medicine · 114d
Cleared Oct 27, 2017
Trocar
K172038 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 114d
Cleared Oct 27, 2017
Cutera enlighten III Laser System
K172077 · GEX
Cutera, Inc.
General & Plastic Surgery · 109d
Cleared Oct 27, 2017
SANGRAY
K172087 · MOT
Hitachi , Ltd.
Radiology · 108d
Cleared Oct 27, 2017
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
K172133 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 105d
Cleared Oct 27, 2017
LINACwatch, LinacView
K172534 · IYE
Qualiformed Sarl
Radiology · 66d
Cleared Oct 27, 2017
Infinitt PACS 7.0
K172803 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 39d
Cleared Oct 27, 2017
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
K172815 · PGY
Shenzhen Beacon Display Technology...
Radiology · 39d
Cleared Oct 27, 2017
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low...
K173104 · OQG
Total Joint Orthopedics, Inc.
Orthopedic · 28d
Cleared Oct 27, 2017
Abbott Architect Free T4
K173122 · CEC
Abbott Laboratories
Chemistry · 28d
Cleared Oct 27, 2017
ASPIRE Cristalle
K173132 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 28d
Cleared Oct 27, 2017
Biim Diagnostic Ultrasound System
K173138 · IYO
Biim Ultrasound AS
Radiology · 28d
Cleared Oct 27, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
K173184 · ODG
Boston Scientific
Gastroenterology & Urology · 28d
Cleared Oct 26, 2017
Healing Cap Multi-Unit Titanium
K171142 · NHA
Nobel Biocare AB
Dental · 191d
Cleared Oct 26, 2017
Intra-Lock Bone Fixation System
K171831 · DZL
Intra-Lock International, Inc.
Dental · 128d
Cleared Oct 26, 2017
Celerity ECG Cable Accessory Pack
K171931 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 120d
Cleared Oct 26, 2017
Omnia Medical VBR
K172323 · MQP
Omnia Medical, LLC
Orthopedic · 86d
Cleared Oct 26, 2017
Rhapsody H-30 Holmium Laser System
K172325 · GEX
Cook Incorporated
General & Plastic Surgery · 86d