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
457–480 of 490
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Oct 28, 2005
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
DEN050006 · NQH
Cardiomems, Inc.
Cardiovascular · 80d
Not Cleared May 19, 2005
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
DEN050002 · NSF
Wako Chemicals USA, Inc.
Immunology · 42d
Not Cleared May 09, 2005
TAG-IT CYSTIC FIBROSIS KIT
DEN050004 · NUA
Tm Bioscience Corporation
Pathology · 34d
Not Cleared Apr 18, 2005
DECAPINOL ORAL RINSE
DEN050001 · NTO
Sinclair Pharmaceuticals Limited
Dental · 84d
Not Cleared Apr 18, 2005
PAXGENE BLOOD RNA SYSTEM
DEN050003 · NTW
Preanalytix GmbH
Pathology · 49d
Not Cleared Dec 23, 2004
AMPLICHIP CYP450 TEST, MODEL 04381866190
DEN040011 · NTI
Roche Molecular Systems, Inc.
Chemistry · 3d
Not Cleared Dec 23, 2004
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
DEN040012 · NSU
Affymetrix, Inc.
Toxicology · 50d
Not Cleared Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
DEN040010 · NTH
Vysis
Pathology · 61d
Not Cleared Nov 04, 2004
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
DEN040009 · MRX
Hamilton Thorne Biosciences
Obstetrics & Gynecology · 71d
Not Cleared Oct 12, 2004
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
DEN040007 · NRV
Digital Angel Corporation
General Hospital · 69d
Not Cleared Aug 24, 2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL...
DEN040002 · NQL
Perkinelmer Life Sciences, Inc.
Chemistry · 53d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008 · NRP
Microgenics Corp.
Chemistry · 41d
Not Cleared Jun 25, 2004
CELLERATION MIST THERAPY SYSTEM
DEN040004 · NRB
Celleration
General & Plastic Surgery · 57d
Not Cleared May 21, 2004
GLUCATELL
DEN040003 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 60d
Not Cleared Jan 21, 2004
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT
DEN040001 · NQI
Advanced Diagnostic Systems
Pathology · 19d
Not Cleared Dec 17, 2003
FACTOR V LEIDEN KIT
DEN030005 · NPQ
Roche Diagnostics Corp.
Pathology · 9d
Not Cleared Jul 08, 2003
WEST NILE VIRUS IGM CAPTURE ELISA
DEN030004 · NOP
Panbio Limited
Microbiology · 5d
Not Cleared Jun 16, 2003
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
DEN030002 · NGS
Spectral Diagnostics, Inc.
Microbiology · 63d
Not Cleared Apr 30, 2003
NIOX ARTICLE NO: 02-1000
DEN030001 · MXA
Aerocrine AB
Toxicology · 43d
Not Cleared Jan 31, 2003
BREASTVIEW VISUAL MAPPING SYSTEM
DEN020001 · NKA
Assurance Medical
Obstetrics & Gynecology · 248d
Not Cleared Aug 20, 2002
RETROX
DEN020003 · NIX
Auric Hearing Systems, Inc.
Ear, Nose, Throat · 60d
Not Cleared Aug 01, 2001
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 51d
Not Cleared Feb 16, 2001
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
DEN000008 · NDS
Life Technologies, Inc.
Gastroenterology & Urology · 59d
Not Cleared Nov 20, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
DEN000010 · NBC
Biosite Incorporated
Chemistry · 5d