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
19537–19560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2020
Ureterorenoscope System
K201293 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 71d
Cleared Jul 24, 2020
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
K201321 · HRS
DePuy Synthes
Orthopedic · 67d
Cleared Jul 24, 2020
DemeMASK
K201479 · FXX
Demetech Corporation
General Hospital · 50d
Cleared Jul 23, 2020
Pre-Seed™ Fertility Lubricant
K193450 · PEB
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 223d
Cleared Jul 23, 2020
EVA 15 Insufflator
K193520 · HIF
Palliare , Ltd.
Obstetrics & Gynecology · 217d
Cleared Jul 23, 2020
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound...
K200090 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 189d
Cleared Jul 23, 2020
LG Pra. L Derma LD Scalp Care
K200464 · OAP
Lg Electronics.Inc
General & Plastic Surgery · 148d
Cleared Jul 23, 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200738 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 122d
Cleared Jul 23, 2020
Vivid E80/ Vivid E90/ Vivid E95
K200743 · IYN
Ge Medical Systems Ultrasound And
Radiology · 122d
Cleared Jul 23, 2020
Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
K201083 · MBI
Parcus Medical, LLC
Orthopedic · 91d
Cleared Jul 23, 2020
Canon non-mydriatic retinal camera CR series
K201122 · HKI
Canon, Inc.
Ophthalmic · 87d
Cleared Jul 23, 2020
AVVIGO Guidance System
K201713 · DQK
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jul 23, 2020
1717SCV, 1717SGV
K201796 · MQB
Rayence Co., Ltd.
Radiology · 23d
Cleared Jul 22, 2020
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT...
K192511 · BTO
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 314d
Cleared Jul 22, 2020
Reprocessed BRK Transseptal Needle
K192998 · NMK
Innovative Health, LLC
Cardiovascular · 268d
Cleared Jul 22, 2020
SOMATOM On.site and On.scene
K193277 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 238d
Cleared Jul 22, 2020
Empty EVA Bag
K193528 · KPE
Haemotronic S.P.A.
General Hospital · 216d
Cleared Jul 22, 2020
Duranext Abutments
K200355 · NHA
Elegant Dental Corp.
Dental · 160d
Cleared Jul 22, 2020
DAC Dynamic Active Compression Plate
K200513 · HRS
Pioneer Surgical Technology, Inc.,...
Orthopedic · 142d
Cleared Jul 22, 2020
Caption Interpretation Automated Ejection Fraction Software
K200621 · QIH
Caption Health
Radiology · 135d
Cleared Jul 22, 2020
Rubicon SA System
K200654 · MNR
Dymedix Diagnostics, Inc.
Anesthesiology · 132d
Cleared Jul 22, 2020
8ch Flex Suite
K200836 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 113d
Cleared Jul 22, 2020
Gamma3 System
K200869 · HSB
Stryker Trauma GmbH
Orthopedic · 112d
Cleared Jul 22, 2020
InMode RF Multi-System
K201150 · GEI
Inmode , Ltd.
General & Plastic Surgery · 84d