Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
73921–73944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 03, 2003
BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
K022521 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 157d
Cleared Jan 03, 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · CBK
Respironics, Inc.
Anesthesiology · 105d
Cleared Jan 03, 2003
TROPHYPAN
K023346 · MUH
Trophy Radiologie
Radiology · 88d
Cleared Jan 03, 2003
USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
K023358 · FGB
Acmi Corporation
Gastroenterology & Urology · 88d
Cleared Jan 03, 2003
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101
K023373 · IYX
Gvi Technology Partners
Radiology · 87d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · GMZ
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Jan 03, 2003
CASSETTE/URINE HCG
K023638 · LCX
Ind Diagnostic, Inc.
Chemistry · 65d