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

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176,076 results
167377–167400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1980
CONCEPT ENDOTRACHEAL TUBE
K801213 · BTR
Concept, Inc.
Anesthesiology · 8d
Cleared May 28, 1980
DEN-MAT DENTIN BONDING AGENT
K801216 · KLE
Den-Mat Corp.
Dental · 7d
Cleared May 23, 1980
CYCLOPAC CP100 TENS BANDAGE
K800576 · GZJ
Cyclotechnical Medical Indust., Inc.
Neurology · 69d
Cleared May 23, 1980
LIBERATOR/STROLLER II SYSTEM
K800742 · BYJ
Cryogenic Assoc.
Anesthesiology · 50d
Cleared May 23, 1980
WINDSOR
K800865 · BZR
Trident Dental, Inc.
Anesthesiology · 37d
Cleared May 23, 1980
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE
K800899 · KZJ
Miles Laboratories, Inc.
Microbiology · 35d
Cleared May 23, 1980
R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.
K800930 · DRX
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122
K800931 · DSA
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120
K800932 · DSA
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)
K800935 · DRX
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171
K800936 · LDD
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176
K800937 · LDD
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
THAYER-MARTIN AGAR
K800977 · JTY
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MUELLER HINTIN AGAR W/5% SHEEP BLOOD
K800979 · JTZ
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
HEXTOEN ENTERIC AGAR
K800980 · JSI
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
SALMONELLA SHIGELLA AGAR
K800982 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MACCONKEY AGAR
K800983 · JSI
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
EOSIN METHYLENE BLUE AGAR, LEVINE
K800984 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
THIOGLYCOLLATE MED. W/O INDICATOR
K800985 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
K801005 · BTR
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 25d
Cleared May 23, 1980
3M R.F. CURRENT SUPPRESSOR
K801041 · DSA
3M Company
Cardiovascular · 21d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051 · CFR
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052 · CFR
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071 · CGA
Sherwood Medical Industries
Chemistry · 17d