FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
27961–27984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2017
20G x 5/8 Pro-Lock CT Safety Infusion Set
K171333 · PTI
Medcomp (Dba Medical Components, Inc.)
General Hospital · 71d
Cleared Jul 18, 2017
Arterys Viewer
K171544 · LLZ
Arterys, Inc.
Radiology · 53d
Cleared Jul 18, 2017
ES2 Neuromonitoring Accessory Instruments
K171807 · PDQ
Stryker Corporation
Neurology · 29d
Cleared Jul 18, 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound...
K171824 · IYO
Edan Instruments, Inc.
Radiology · 29d
Cleared Jul 18, 2017
Inspire ICE aka Inspire ICE Clear Brackets
K171844 · NJM
Ormco Corporation
Dental · 28d
Cleared Jul 17, 2017
U2 Femoral Head
K162957 · LPH
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jul 17, 2017
BD ChloraShield IV Dressing with CHG Antimicrobial
K170407 · FRO
Avery Dennison Belgie Bvba
General & Plastic Surgery · 157d
Cleared Jul 17, 2017
!M1
K170607 · IZL
Solutions For Tomorrow AB
Radiology · 138d
Cleared Jul 17, 2017
Genius Total Knee System
K170613 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 138d
Cleared Jul 17, 2017
3D Endo Software
K171115 · LLZ
Dentsply Sirona
Radiology · 94d
Cleared Jul 17, 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
K171404 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 66d
Cleared Jul 14, 2017
VITROS Chemistry Products hsCRP Reagent
K160712 · DCK
Ortho-Clinical Diagnostics
Chemistry · 486d
Cleared Jul 14, 2017
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
K162153 · HWC
Ascension Orthopedics
Orthopedic · 346d
Cleared Jul 14, 2017
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
K162698 · JLW
Shenzhen New Industries Biomedical...
Chemistry · 290d
Cleared Jul 14, 2017
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single...
K162707 · GDW
Golden Stapler Surgical Co., Ltd.
General & Plastic Surgery · 289d
Cleared Jul 14, 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · DSY
Vascutek, Ltd.
Cardiovascular · 282d
Cleared Jul 14, 2017
Bonafix TWO - Dental Implant System
K162853 · DZE
Bonafix Surgical and Dental Implants
Dental · 276d
Cleared Jul 14, 2017
ViMove2
K163150 · IKN
Dorsavi, Ltd.
Neurology · 247d
Cleared Jul 14, 2017
Neodent Implant System - GM Line
K163194 · DZE
Jjgc Industria E Comercio DE...
Dental · 241d
Cleared Jul 14, 2017
Soules Intrauterine Insemination Catheter
K163318 · MQF
Cook Incorporated
Obstetrics & Gynecology · 233d
Cleared Jul 14, 2017
RTHawk, HeartVista Cardiac Package
K170090 · LNH
Heartvista, Inc.
Radiology · 185d
Cleared Jul 14, 2017
In2Bones Fracture and Correction System
K170518 · HRS
In2bones USA, LLC
Orthopedic · 143d
Cleared Jul 14, 2017
sensiFirm
K170637 · PBX
El Global Trade, Ltd.
General & Plastic Surgery · 134d
Cleared Jul 14, 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with...
K170686 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 129d