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
79849–79872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2001
RITA STARBURST XLI ELECTROSURGICAL DEVICE
K010060 · GEI
Rita Medical Systems
General & Plastic Surgery · 15d
Cleared Jan 22, 2001
GLUTARTEST 1 REAGENT STRIP
K002011 · MSY
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 203d
Cleared Jan 22, 2001
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002621 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
INSTACCULT
K002930 · KHE
Medtek Diagnostics, LLC
Hematology · 124d
Cleared Jan 22, 2001
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A...
K003042 · LPL
Joe B. Goldberg, O.D.
Ophthalmic · 115d
Cleared Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323 · FTL
Davol, Inc.
General & Plastic Surgery · 90d
Cleared Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · KLB
Syva Co., Dade Behring, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · DCN
Wako Chemicals USA, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · LLZ
Philips Medical Systems North...
Radiology · 76d
Cleared Jan 22, 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · BSZ
Draeger Medical, Inc.
Anesthesiology · 63d
Cleared Jan 22, 2001
VIEW READING STATION
K003688 · LLZ
Electromed Intl., Ltd.
Radiology · 53d
Cleared Jan 22, 2001
ADVANTAGE THC/COCAINE TEST
K003708 · DIO
Advantage Diagnostics Corp.
Toxicology · 52d
Cleared Jan 22, 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · LJM
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 20d
Cleared Jan 19, 2001
RENEW NEUROSTIMULATION SYSTEM
K000852 · GZF
Advanced Neuromodulation Systems
Neurology · 310d
Cleared Jan 19, 2001
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE...
K000884 · NDZ
Becton Dickinson Biosciences
Microbiology · 305d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · DRT
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Jan 19, 2001
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
K003358 · KPS
Smv America
Radiology · 85d
Cleared Jan 19, 2001
ACROTHERM
K003368 · DWJ
Aquarius Medical Corp.
Cardiovascular · 81d
Cleared Jan 19, 2001
EDTA ROOT CANAL CLEANSER
K003422 · KJJ
Super Glide, Inc.
Dental · 77d
Cleared Jan 19, 2001
CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
K003481 · LMC
Codonics, Inc.
Radiology · 71d
Cleared Jan 19, 2001
NETRA WORKSTATION AND NETRAMD SOFTWARE
K003484 · LLZ
Scimage, Inc.
Radiology · 71d