FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72793–72816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2003
SMARTTROAE
K023859 · EWO
Intelligent Hearing Systems
Ear, Nose, Throat · 49d
Cleared Jan 08, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
K023895 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jan 08, 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 30d
Cleared Jan 08, 2003
MBC SERIES
K024059 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 30d
Cleared Jan 08, 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · DWF
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 08, 2003
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K024294 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 15d
Cleared Jan 07, 2003
SPECATH CENTRAL VENOUS CATHETER KITS
K021130 · FOZ
Special Medical Co. , Ltd.
General Hospital · 273d
Cleared Jan 07, 2003
ACCULEAF
K021338 · IYE
Direx Systems Corp.
Radiology · 256d
Cleared Jan 07, 2003
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL...
K022023 · KLA
Clinical Innovations, Inc.
Gastroenterology & Urology · 201d
Cleared Jan 07, 2003
SYNTHES RESORBABLE CONTOURABLE MESH
K022844 · JEY
Synthes (Usa)
Dental · 133d
Cleared Jan 07, 2003
UNISIGHT SYSTEM WITH UNIGATE
K023394 · LLZ
Electronic Business Machine Co., Ltd....
Radiology · 90d
Cleared Jan 07, 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K023427 · DRN
Cardiomedics, Inc.
Cardiovascular · 88d
Cleared Jan 07, 2003
HCP DICOM NET
K023467 · LLZ
Softlink International, Inc.
Radiology · 83d
Cleared Jan 07, 2003
UNIPACS WORKSTATION
K023476 · LLZ
Universal Pacs, Inc.
Radiology · 83d
Cleared Jan 07, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K023728 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 62d
Cleared Jan 07, 2003
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
K023840 · CKB
Bayer Diagnostics Corp.
Chemistry · 50d
Cleared Jan 07, 2003
OBC-250-PAN BREAST ARRAY COIL
K024208 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Jan 06, 2003
CUSTODIOL HTK SOLUTION
K020924 · KDL
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 291d
Cleared Jan 06, 2003
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
K023410 · JJY
Maine Standards Co.
Chemistry · 88d
Cleared Jan 06, 2003
SERAQUEST ANTI-THYROGLOBULIN
K023592 · DDC
Quest Intl., Inc.
Immunology · 73d
Cleared Jan 06, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K024048 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 06, 2003
SHANGHAI HUAMAO POWDER-FREE YELLOW VINYL EXAM GLOVES
K024154 · LYZ
Shanghai Huamao Gloves Co., Ltd.
General Hospital · 20d
Cleared Jan 06, 2003
NIM-PRS
K024316 · IKN
Medtronic Xomed, Inc.
Neurology · 11d
Cleared Jan 03, 2003
CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM
K022126 · HAW
Medtronic Surgical Navigation...
Neurology · 186d