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

Filters: Cleared only ×
175,820 results
18721–18744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2020
SimpleSENSE
K201669 · DXH
Nanowear, Inc.
Cardiovascular · 140d
Cleared Nov 06, 2020
Aqueduct 100 Plus Cervical Dilation Balloon Catheter
K202427 · PON
Gtimd, LLC
Obstetrics & Gynecology · 73d
Cleared Nov 06, 2020
BioShield biopsy valve EUS - Linear
K202583 · ODD
STERIS Corporation
Gastroenterology & Urology · 59d
Cleared Nov 06, 2020
ATEC Lateral Interbody System
K202587 · MAX
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Nov 06, 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression...
K202589 · HWC
Medartis AG
General Hospital · 59d
Cleared Nov 06, 2020
Clio Prime and Clio Pedo
K202664 · MUH
Sota Precision Optics, Inc. Dba Sota...
Radiology · 53d
Cleared Nov 06, 2020
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution...
K203061 · FLE
STERIS Corporation
General Hospital · 29d
Cleared Nov 06, 2020
Mecta-C Stand Alone Extension
K203076 · OVE
Medacta International S.A.
Orthopedic · 24d
Cleared Nov 05, 2020
Eclipse DermaFlex Cannula
K200017 · FMI
Eclipse Medcorp, LLC
General Hospital · 307d
Cleared Nov 05, 2020
Gabriel 3 Way EnFit Valve
K201741 · PIF
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 133d
Cleared Nov 05, 2020
GR-17 Resin System
K201827 · EBG
Pro3dure Medical GmbH
Dental · 126d
Cleared Nov 05, 2020
OtoSet- Ear Cleaning System
K201877 · KYZ
Safkan, Inc.
Ear, Nose, Throat · 121d
Cleared Nov 05, 2020
MammaPrint
K201902 · NYI
Agendia, Inc.
Pathology · 120d
Cleared Nov 05, 2020
SPY-PHI System with SPY-PHI Fluorescence Assessment Software
K202244 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 87d
Cleared Nov 05, 2020
Salvo® Spine System
K202476 · NKB
Spine Wave, Inc.
Orthopedic · 69d
Cleared Nov 05, 2020
LOBO Vascular Occlusion System (model LOBO-5)
K203025 · KRD
Okami Medical
Cardiovascular · 34d
Cleared Nov 05, 2020
KASILOF Cervical Plate System
K203154 · KWQ
Kahtnu Surgical, Inc.
Orthopedic · 14d
Cleared Nov 04, 2020
Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
K182084 · KCT
Sweden & Martina S.P.A.
General Hospital · 825d
Cleared Nov 04, 2020
DigiGuide System
K193499 · DZJ
Protomed, Inc.
Dental · 323d
Cleared Nov 04, 2020
MyHip Planner & Verifier
K200350 · LLZ
Medacta International S.A.
Radiology · 266d
Cleared Nov 04, 2020
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image...
K201840 · GWG
Rebound Therapeutics
Neurology · 125d
Cleared Nov 04, 2020
Monitor B125, Monitor B105
K201941 · MHX
Ge Medical Systems Information...
Cardiovascular · 114d
Cleared Nov 04, 2020
Arietta 65
K202422 · IYN
Hitachi Healthcare Americas
Radiology · 72d
Cleared Nov 04, 2020
Arthrex TightRope II
K202581 · MBI
Arthrex, Inc.
Orthopedic · 57d