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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167473–167496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1980
LITHIUM DILUENT (1500 MM/E)
K800039 · JIH
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
SODIUM/POTASSIUM (100/100 MEQ/E)
K800040 · JIX
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
SODIUM/POTASSIUM 140/5 MEQ/L)
K800041 · JIX
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
LITHIUM STANDARD (1MM/L)
K800042 · JIS
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
CESIUM DILUENT (1.5 MM/L)
K800043 · JIX
Gilford Diagnostics
Chemistry · 14d
Cleared Jan 21, 1980
LDC UVIII FIXED WAVELENGTH ULTRAVIOLET
K800047 · KIE
Laboratory Data Control
Toxicology · 12d
Cleared Jan 17, 1980
HEMO-WEDGE
K790555 · DZN
Parker Laboratories, Inc.
Dental · 304d
Cleared Jan 17, 1980
ANALYTE CORTISOL
K792439 · CGR
Technicon Instruments Corp.
Chemistry · 50d
Cleared Jan 17, 1980
SONACOLOR 6000
K792540 · DXK
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Jan 17, 1980
VENOJECT AUTOSEP
K792587 · JKA
Kimble-Terumo, Inc.
Chemistry · 31d
Cleared Jan 17, 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · CFJ
Hoffmann-La Roche, Inc.
Chemistry · 22d
Cleared Jan 17, 1980
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM
K792662 · KHQ
Micromedic Systems
Chemistry · 22d
Cleared Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671 · JJG
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792679 · GMK
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS, ANTIGEN
K792680 · JWW
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS POS/CONTROL
K792681 · KFH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792682 · GMI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM,
K792684 · GMH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
BLASTOMYCES DERMATITIDIS, ANTISERUM
K792685 · KFH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP, ANTISERUM POSITIVE
K792686 · KFG
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
ASPERGILLUS SP., ANTIGEN
K792687 · JWI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTISERUM
K792688 · GMH
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792689 · GMI
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
COCCIDIOIDES IMMITIS, LATEX AGGLUTI
K792690 · GMG
Meridian Diagnostics, Inc.
Microbiology · 21d