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
146545–146568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
K854180 · CIG
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · CIX
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE
K854182 · CDT
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF URIC ACID
K854185 · KNK
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN-VITRO TEST DETERMINATION OF SGOT (AST)
K854187 · CIS
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K854188 · CEO
Clinical Data, Inc.
Chemistry · 41d
Cleared Nov 25, 1985
CANTROL SPINAL FLUID CONTROL
K854190 · DFI
Canyon Diagnostics, Inc.
Immunology · 41d
Cleared Nov 25, 1985
DIESSE CRP TEST KIT
K854221 · DCK
Marvic Interpharma, Inc.
Immunology · 38d
Cleared Nov 25, 1985
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD
K854366 · CDT
American Monitor Corp.
Chemistry · 27d
Cleared Nov 25, 1985
TDX CORTISOL
K854419 · JFT
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
TDX R OPIATES
K854421 · DJG
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
SPECTRA 724
K854498 · FTC
Daavlin Co.
General & Plastic Surgery · 13d
Cleared Nov 25, 1985
ALT(OPTIMIZED) REAGENT
K854502 · CKA
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
AST(OPTIMIZED) REAGENT
K854503 · CIT
Sigma Diagnostics, Inc.
Chemistry · 13d
Cleared Nov 25, 1985
SHAW SUN SYSTEMS 1000, 2000 & 3200
K854515 · FTC
Shaw Sun Systems
General & Plastic Surgery · 13d
Cleared Nov 25, 1985
TOTAL PROTEIN
K854553 · CEK
American Monitor Corp.
Chemistry · 12d
Cleared Nov 22, 1985
UNILOC TOTAL HIP PROSTHESIS
K851409
Serrano Intl.
Orthopedic · 227d
Cleared Nov 22, 1985
MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
K853392 · FLL
Mon-A-Therm, Inc.
General Hospital · 101d
Cleared Nov 22, 1985
APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT
K853524 · KMC
Intermedics Orthopedics
Orthopedic · 92d
Cleared Nov 22, 1985
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD
K853795 · KWY
Kirschner Medical Corp.
Orthopedic · 72d
Cleared Nov 22, 1985
EXTERNAL MECHANICAL FASTENER
K854068
Wells Johnson Co.
General & Plastic Surgery · 49d
Cleared Nov 22, 1985
CALCITONIN RIA KIT
K854240 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 32d
Cleared Nov 22, 1985
SILICONE OIL 350 CNETISTOKE
K854273 · KRD
Pacific Medical Industries
Cardiovascular · 63d
Cleared Nov 22, 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · CGA
Sterling Diagnostics, Inc.
Chemistry · 25d