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
168313–168336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1980
BK-5203 FACILITATION VIBRATOR ELECTRIC
K800018 · IRO
Fred Sammons, Inc.
Physical Medicine · 19d
Cleared Jan 21, 1980
BK-1544 BE OK SCOOP DISK
K800019 · ILC
Fred Sammons, Inc.
Physical Medicine · 19d
Cleared Jan 21, 1980
WORTHINGTON FLOZYME* CPK (340NM)
K800028 · JHS
Worthington Diagnostic Systems
Chemistry · 14d
Cleared Jan 21, 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · JJX
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Jan 21, 1980
TOTAL ESTRIOL RIA KIT
K800036 · CGI
Amersham Corp.
Chemistry · 14d
Cleared Jan 21, 1980
ALT REAGENT
K800038 · CKA
Gilford Diagnostics
Chemistry · 14d
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