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: Not cleared only ×
490 results
361–384 of 490
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Apr 01, 2015
SpaceOAR System
DEN140030 · OVB
Augmenix, Inc.
Radiology · 182d
Not Cleared Mar 20, 2015
PROLONG
DEN130047 · PIA
Ergon Medical , Ltd.
Gastroenterology & Urology · 487d
Not Cleared Mar 06, 2015
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
DEN130046 · PKA
Somna Therapeutics, LLC
Ear, Nose, Throat · 477d
Not Cleared Feb 19, 2015
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
DEN140044 · PKB
23AndMe
Chemistry · 266d
Not Cleared Feb 12, 2015
ECLIPSE SYSTEM
DEN140020 · PJH
Pelvalon
Gastroenterology & Urology · 233d
Not Cleared Jan 23, 2015
Dexcom Share Direct Secondary Displays
DEN140038 · PJT
Dexcom, Inc.
Chemistry · 39d
Not Cleared Dec 18, 2014
MOERAE SURGICAL MARKING PEN
DEN130004 · PDW
Moerae Matrix, Inc.
General & Plastic Surgery · 591d
Not Cleared Dec 18, 2014
AMIGO REMOTE CATHETER SYSTEM
DEN140009 · PJB
Catheter Robotics, Inc.
Cardiovascular · 303d
Not Cleared Dec 15, 2014
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM
DEN140010 · PJI
Wallac OY
Pathology · 299d
Not Cleared Nov 26, 2014
HEARTFLOW FFRCT
DEN130045 · PJA
Heartflow
Cardiovascular · 387d
Not Cleared Nov 17, 2014
BrainScope Ahead 100
DEN140025 · PIW
Brainscope Company, Inc.
Neurology · 89d
Not Cleared Nov 07, 2014
ZAP-IT!
DEN100024 · OSG
Ecobrands , Ltd.
Neurology · 1520d
Not Cleared Nov 07, 2014
ZANZA-CLICK
DEN130019 · OSG
Tecnimed S.R.L.
Neurology · 617d
Not Cleared Oct 14, 2014
INFLOW INTRAURETHRAL VALVE-PUMP
DEN130044 · PIH
Vesiflo, Inc.
Gastroenterology & Urology · 354d
Not Cleared Sep 22, 2014
T2CANDIDA AND T2DX INSTRUMENT
DEN140019 · PII
T2biosystems, Inc.
Microbiology · 118d
Not Cleared Sep 05, 2014
NEPHROCHECK TEST SYSTEM
DEN130031 · PIG
Astute Medical, Inc.
Chemistry · 457d
Not Cleared Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
DEN120017 · PCB
Medtronic Neurosurgery
Neurology · 609d
Not Cleared Aug 20, 2014
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
DEN140001 · PHF
Kronus Market Development Associates,...
Immunology · 65d
Not Cleared Aug 19, 2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
DEN140016 · PHV
Dexcom, Inc.
Chemistry · 119d
Not Cleared Jun 26, 2014
REWALK
DEN130034 · PHL
Argo Medical Technologies, Inc.
Neurology · 374d
Not Cleared Jun 06, 2014
EEVA 2.0
DEN120015 · PBH
Auxogyn, Inc.
Obstetrics & Gynecology · 651d
Not Cleared May 29, 2014
EUROIMMUN ANTI-PLA2R IFA
DEN140002 · PGV
Euroimmun US
Immunology · 62d
Not Cleared May 13, 2014
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · PGI
Diagnostic Hybrids, Inc.
Microbiology · 81d
Not Cleared May 09, 2014
DEKA ARM SYSTEM
DEN120016 · PAE
Deka Integrated Solutions Corporation
Physical Medicine · 693d