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
140857–140880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1987
MSI HEMATOLOGY CONTROL +
K871067 · JPK
Medical Specialties, Inc.
Hematology · 7d
Cleared Mar 25, 1987
INSTANT HEAT COMPRESS, CHEMICAL TYPE
K871114 · IMD
Lexington Industries
Physical Medicine · 6d
Cleared Mar 24, 1987
OPTI-FIX ACETABULAR COMPONENT
K864857 · JDI
Richards Medical Co., Inc.
Orthopedic · 103d
Cleared Mar 24, 1987
AUTO ENTRY SYSTEM (MATE)
K870425 · IOR
Kg Engineering, Inc.
Physical Medicine · 49d
Cleared Mar 24, 1987
DS-DNA EIA DIAGNOSTIC KIT
K870453 · LJM
Biohytech International, Inc.
Immunology · 62d
Cleared Mar 24, 1987
DEFINED FETAL BOVINE SERUM #A-1111
K870463 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
CHARACTERIZED FETAL BOVINE SERUM #A-1115
K870464 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
6/40 FETAL BOVINE SERUM #A-1110
K870465 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
DEFINED CALF BOVINE SERUM #A-2111
K870466 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151
K870467 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
ADULT BOVINE SERUM
K870468 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
DEFINED EQUINE SERUM #A-3311
K870469 · KIS
Hyclone Laboratories, Inc.
Pathology · 49d
Cleared Mar 24, 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
K870564 · MSJ
Atlantic Antibodies
Immunology · 42d
Cleared Mar 24, 1987
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624 · DHB
Ventrex Laboratories, Inc.
Immunology · 39d
Cleared Mar 24, 1987
MODEL 102 PH METER
K870811 · LRI
Mesa Medical, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 24, 1987
SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL
K870862 · MSJ
Atlantic Antibodies
Immunology · 21d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C3
K870930 · CZM
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Mar 24, 1987
TINA-QUANT(R) (A) C4
K870931 · DBI
Boehringer Mannheim Corp.
Immunology · 15d
Cleared Mar 24, 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
K870994 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 13d
Cleared Mar 24, 1987
FUKUDA DENSHI MODEL FCP-15
K871025 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 8d
Cleared Mar 23, 1987
MODIFIED DRAGER SPHYGMOMED
K862427 · DXN
Draeger Medical, Inc.
Cardiovascular · 270d
Cleared Mar 23, 1987
COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE
K863424 · GWN
Micromedical Technologies, Inc.
Neurology · 200d
Cleared Mar 23, 1987
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Mar 23, 1987
HEART TRACK
K864293 · DXH
Cardio Telemetric Systems, Inc.
Cardiovascular · 143d