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
166465–166488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · DSI
General Electric Co.
Cardiovascular · 23d
Cleared Sep 26, 1980
FIBRI QUIK
K802117 · GJA
General Diagnostics
Hematology · 22d
Cleared Sep 26, 1980
ISOLETTE INCUBATOR C-100
K802126 · FMZ
Narco Air-Shields
General Hospital · 22d
Cleared Sep 26, 1980
IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
K802128 · JWW
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
IMMUNODIFFUSION REAGENTS/SEROLOGICAL
K802129 · GMI
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
IMMUNO. IDENTIFICATION OF H. CAPSULATUM
K802130 · GMJ
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K802133 · KRB
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Sep 26, 1980
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 21d
Cleared Sep 26, 1980
2C 7140 HEATED HUMIDIFER CANNISTER
K802145 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 21d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPE
K802148 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 18d
Cleared Sep 26, 1980
SHERWOOD VENTILATORY MUSCLE TRAINER
K802165 · BYW
Sherwood Medical Co.
Anesthesiology · 18d
Cleared Sep 26, 1980
URIHESIVE SYSTEM
K802172 · KNX
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 26, 1980
URIHESIVE STRIPS
K802173 · KNX
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 26, 1980
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · KDQ
Sherwood Medical Co.
General Hospital · 17d
Cleared Sep 26, 1980
HS10 PORTABLE OPERATING ROOM MONITOR
K802184 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 16d
Cleared Sep 26, 1980
DISPOSABLE NURSES CAP
K802186 · FYF
Anago, Inc.
General & Plastic Surgery · 16d
Cleared Sep 26, 1980
DENTLOID
K802189 · ELW
U.S. Shizai Corp.
Dental · 16d
Cleared Sep 26, 1980
BOUNDARY SINGLE-USE DRAPES
K802192 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 16d
Cleared Sep 26, 1980
BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM
K802198 · DXG
Biometric Analysis Group, Inc.
Cardiovascular · 16d
Cleared Sep 26, 1980
RION DIAGNOSTIC AUDIOMETER
K802207 · EWO
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 15d
Cleared Sep 26, 1980
CONICAL TIPPED CENTRIFUGE TUBE 15M
K802210 · JQC
Scientific Specialties, Inc.
Chemistry · 14d
Cleared Sep 26, 1980
TENDER-SORB DRAIN SPONGES
K802225 · NAB
Kendall Research Center
General & Plastic Surgery · 14d
Cleared Sep 26, 1980
SECHRIST SERIES 3500 AIR-OXYGEN MIXER
K802226 · BZR
Sechrist Industries, Inc.
Anesthesiology · 14d
Cleared Sep 26, 1980
ANASTIM II TRANSCUTANEOUS ELECTRICAL
K802227 · GZJ
Biostim, Inc.
Neurology · 14d