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
173161–173184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1977
CREATININE
K771834 · CGX
Gamma Enterprises, Inc.
Chemistry · 43d
Cleared Nov 03, 1977
SERUM IRON
K771838 · JIY
Gamma Enterprises, Inc.
Chemistry · 43d
Cleared Nov 03, 1977
CPK COLOR TEST KIT
K771849 · CGS
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Nov 03, 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
K771856 · CGX
Stanbio Laboratory
Chemistry · 35d
Cleared Nov 03, 1977
STAC SYSTEM-ADDI. ANALYTES
K771939 · JJF
Technicon Instruments Corp.
Immunology · 17d
Cleared Nov 03, 1977
CARDIAC OUTPUT THERMODILUTION MODULE
K771991 · DXG
Abbott Laboratories
Cardiovascular · 15d
Cleared Nov 03, 1977
HUMAN REFERENCE SERUM C4 COMPLEMENT
K772003 · DAK
G.D. Searle and Co.
Immunology · 13d
Cleared Nov 03, 1977
HUMAN C4 COMPLEMENT CONTROL SERUM
K772004 · DBI
G.D. Searle and Co.
Immunology · 13d
Cleared Nov 03, 1977
CARDIAC PULSE GENERATOR, MODEL 150L
K772026 · DXY
Telectronics, Inc.
Cardiovascular · 7d
Cleared Nov 03, 1977
BIPOLAR PACEMAKER MODEL 224
K772057 · DXY
Intermedics, Inc.
Cardiovascular · 3d
Cleared Nov 03, 1977
LEAD ADAPTOR KIT MODEL 5866-21
K772058 · DTD
Medtronic Vascular
Cardiovascular · 3d
Cleared Nov 02, 1977
DHEA TEST SET
K771793 · CIY
Wien Laboratories, Inc.
Immunology · 41d
Cleared Nov 02, 1977
ALKALINE PHOSPHATASE
K771829 · CJE
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
INORGANIC PHOSPHORUS
K771835 · CEO
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
POTASSIUM
K771837 · CEM
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
SODIUM
K771839 · JGS
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Nov 02, 1977
TEMP-TESTER
K771847 · GXB
Jablecki, Charles, Dr.
Chemistry · 35d
Cleared Nov 02, 1977
NIMETIC POLISHING PASTE
K771852 · EJR
Espe GmbH (Us)
Dental · 34d
Cleared Nov 02, 1977
DIAG. ULTRASOUND B-SCANNER
K771869 · HGL
Accusonics, Inc.
Obstetrics & Gynecology · 30d
Cleared Nov 02, 1977
IMPORTED PAIN CONTROL DEVICE
K771885 · GZJ
Empi
Neurology · 28d
Cleared Nov 02, 1977
CATHETER, UMBILICAL, VICRA
K771891 · FOS
Travenol Laboratories, S.A.
General Hospital · 27d
Cleared Nov 02, 1977
DISPOSABLE ELHCTRODE
K771893 · GYB
Chase Medical Services
Chemistry · 117d
Cleared Nov 02, 1977
MINICLINIC TM
K771922 · DTC
Instromedix, Inc.
Cardiovascular · 20d
Cleared Nov 02, 1977
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP
K771925 · KES
Harleco
Pathology · 19d