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
25969–25992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2018
Diamond Orthopedic Bone Fixation Screws and Pins
K180932 · HWC
Diamond Orthopedic, LLC
Orthopedic · 29d
Cleared May 09, 2018
Halcyon
K181032 · IYE
Varian Medical Systems, Inc.
Radiology · 21d
Cleared May 08, 2018
Trident Extremity Fixation System
K171690 · HRS
Trident Orthopedics
Orthopedic · 335d
Cleared May 08, 2018
VENTANA CD30 (Ber-H2) RxDx Assay
K172471 · DEH
Ventana Medical Systems, Inc.
Medical Genetics · 266d
Cleared May 08, 2018
A-CIFT SoloFuse
K172484 · OVE
Spinefrontier, Inc.
Orthopedic · 264d
Cleared May 08, 2018
Fetzer Medical Gynecological Forceps
K172661 · HCZ
Fetzer Medical GmbH & Co. KG
Obstetrics & Gynecology · 245d
Cleared May 08, 2018
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
K173004 · FDS
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 223d
Cleared May 08, 2018
STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX,...
K173347 · MAX
Centinel Spine, Inc.
Orthopedic · 195d
Cleared May 08, 2018
BioStamp nPoint
K173510 · DRG
Mc10, Inc.
Cardiovascular · 176d
Cleared May 08, 2018
Glidesheath Slender
K173831 · DYB
Terumo Medical Corporation
Cardiovascular · 141d
Cleared May 08, 2018
MyoSure MANUAL Tissue Removal Device
K173901 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 137d
Cleared May 08, 2018
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc...
K173912 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 137d
Cleared May 08, 2018
Meron Plus QM
K180386 · EMA
Voco GmbH
Dental · 85d
Cleared May 08, 2018
Empower H100, Cyber Ho 100, Litho 100
K180922 · GEX
Quanta System Spa
General & Plastic Surgery · 29d
Cleared May 07, 2018
Endopath Electrosurgery Probe Plus II
K180031 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 123d
Cleared May 07, 2018
Weinmann Tracheostomy Exchange Set
K180034 · JOH
Cook Incorporated
Anesthesiology · 123d
Cleared May 07, 2018
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs...
K180079 · BZQ
Hill-Rom, Inc.
Anesthesiology · 117d
Cleared May 07, 2018
Afinion HbA1c Dx
K180296 · PDJ
Alere Technologies AS
Chemistry · 94d
Cleared May 04, 2018
3.0 Dynamic TiBase
K162021 · NHA
Talladium Espana, SL
Dental · 652d
Cleared May 04, 2018
URIS OMNI System
K172100 · DZE
Truabutment, Inc.
Dental · 297d
Cleared May 04, 2018
Trackit T4 EEG Amplifier
K172271 · GWQ
Lifelines , Ltd.
Neurology · 280d
Cleared May 04, 2018
Cervage
K172568 · ODP
Precifit Medical, Ltd.
Orthopedic · 252d
Cleared May 04, 2018
Caldera Medical Transobturator Helical Introducer, Left
K172614 · PWJ
Caldera Medical, Inc.
Gastroenterology & Urology · 246d
Cleared May 04, 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345 · JIN
Taidoc Technology Corporation
Chemistry · 192d