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
163729–163752 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1981
902 NA/K
K811896 · JGS
Corning Medical & Scientific
Chemistry · 22d
Cleared Jul 23, 1981
CENTURY LIFT TRANSFER SYSTEM
K811899 · FSA
Century Manufacturing Co.
General Hospital · 22d
Cleared Jul 23, 1981
CENTURY BATHING SYSTEM
K811901 · FNG
Century Manufacturing Co.
General Hospital · 22d
Cleared Jul 23, 1981
FOLLICLE STIMULATING HORMONE DIRECT RIA
K811905 · CGJ
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
DHEA-SULFATE DIRECT RIA KIT(125I)
K811906 · JKC
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · JLS
Immunalysis Corporation
Chemistry · 22d
Cleared Jul 23, 1981
HELENA VMA-SMC CONTROL
K811912 · JJX
Helena Laboratories
Chemistry · 22d
Cleared Jul 23, 1981
I.V. ADMIN. SETS FOR THE AMP MARK IV PMP
K811917 · FRN
American Medical Products, Inc.
General Hospital · 21d
Cleared Jul 23, 1981
KODAK EKTACHEM 400 ANALYZER
K811919 · JJE
Eastman Kodak Company
Chemistry · 21d
Cleared Jul 23, 1981
HITACHI 705 CALIBRATOR
K811921 · JIX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 23, 1981
45DEGREES SWIVEL ELBOW
K811922 · BZA
Dhd Medical Products Div. Diemolding...
Anesthesiology · 21d
Cleared Jul 23, 1981
COAT-A-COUNT DIGOXIN RIA
K811932 · DPO
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jul 23, 1981
VITATRON 88
K811939 · GZJ
Vitatronics
Neurology · 17d
Cleared Jul 23, 1981
IMMOPHASE INSULIN (125I) RADIOASSAY
K811953 · CFP
Corning Medical & Scientific
Hematology · 15d
Cleared Jul 23, 1981
CAMPYPAK
K811957 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Jul 23, 1981
VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
K811966 · FMI
Visitec Co.
General Hospital · 13d
Cleared Jul 23, 1981
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · JTY
Abbott Laboratories
Microbiology
Cleared Jul 21, 1981
FREEZE DRIED PAPAIN
K810803 · KSK
Biological Corp. of America
Immunology · 119d
Cleared Jul 21, 1981
OXYGEN CONTROLLER MODEL 145
K812038
Medix Medical Electronics (U.S.A.), Inc.
Cardiovascular
Cleared Jul 20, 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887 · DXY
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Jul 20, 1981
WEBER/STUEHMER HIP JOINT ENDOPROSTHESIS
K811119
Allo Pro Corp.
Orthopedic · 87d
Cleared Jul 20, 1981
PACEMAKER PROGRAMMER #2010
K811217 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 77d
Cleared Jul 20, 1981
CATH-DAP
K811277 · KOD
Northwest Alabama Urological Assoc.
Gastroenterology & Urology · 73d
Cleared Jul 20, 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
K811318 · LDF
Medtronic Vascular
Cardiovascular · 69d