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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148633–148656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · DXK
Del Mar Avionics
Cardiovascular · 175d
Cleared Jun 10, 1985
CALCIUM
K850929 · CIC
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
GLUCOSE
K850930 · CGE
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
CHLORIDE
K850935 · CHJ
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
UREA
K850937 · CDW
Dilab, Inc.
Chemistry · 95d
Cleared Jun 10, 1985
LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
K851402 · DXT
Medi-Tech, Inc.
Cardiovascular · 62d
Cleared Jun 10, 1985
EPILATOR 8500
K851413 · KCX
Lois Yee Cosmetics, Inc.
General & Plastic Surgery · 62d
Cleared Jun 10, 1985
WILLCOGEN MENINGITIDIS KIT ZL25
K851691 · GTJ
Wellcome Diagnostics
Microbiology · 48d
Cleared Jun 10, 1985
CLINICAL CHEMISTRY ANALYTICAL SYSTEM
K851933 · JJF
Allied Instrumentation Laboratory
Chemistry · 39d
Cleared Jun 10, 1985
G-GT REAGENT
K851999 · JQB
Alpkem Corp.
Chemistry · 34d
Cleared Jun 10, 1985
AMY REAGENT
K852001 · JFJ
Alpkem Corp.
Chemistry · 34d
Cleared Jun 10, 1985
TP BIURET REAGENT
K852006 · CEK
Alpkem Corp.
Chemistry · 34d
Cleared Jun 10, 1985
GENTAMICIN KIT(FPIA)
K852013 · LCQ
Windsor Laboratories, Inc.
Toxicology · 32d
Cleared Jun 10, 1985
SED-FIX CONCENTRATE
K852045 · IER
Surgipath Medical Industries, Inc.
Pathology · 32d
Cleared Jun 10, 1985
CYTO-TEK CENTRIFUGE
K852117 · IFB
Miles Laboratories, Inc.
Pathology · 26d
Cleared Jun 10, 1985
GLUCOSE(TRINDER) REAGENT
K852130 · CGA
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 10, 1985
BUN(ENDPOINT) REAGENT
K852131 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 10, 1985
SERUM IRON/VIBC REAGENT SET
K852161 · JIY
Livonia Diagnostics, Inc.
Toxicology · 21d
Cleared Jun 10, 1985
YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE
K852246 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 18d
Cleared Jun 07, 1985
VITAPEP
K844963 · BWF
Vitalograph , Ltd.
Anesthesiology · 165d
Cleared Jun 07, 1985
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K844992 · GWF
Bio-Logic Systems Corp.
Neurology · 163d
Cleared Jun 07, 1985
EMPTY SOLUTION TRANSFER CONTAINER
K850035 · KPE
The Healthcare Group Laboratories, Inc.
General Hospital · 151d
Cleared Jun 07, 1985
NATURAL MOTHER BREAST PUMP
K850753 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 102d
Cleared Jun 07, 1985
PASSY-MUIR TRACH VALVE
K851016 · BTO
Passy & Passy, Inc.
Anesthesiology · 87d