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
166993–167016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1980
ROLLS ROLLITE WHEELCHAIR
K801557 · IOR
Invacare Corp.
Physical Medicine · 13d
Cleared Jul 21, 1980
CYBREX PHENYTOIN
K801565
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
CYBREX PHENOBARBITAL
K801566
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
CYBREX THEOPHYLLINE
K801567
Abbott Laboratories
Toxicology · 13d
Cleared Jul 21, 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · ELW
Dentsply Intl.
Dental · 10d
Cleared Jul 21, 1980
FIBER OPTIC ILLUMINATOR
K801591 · EAY
Lares Manufacturing Co., Inc.
Dental · 10d
Cleared Jul 21, 1980
FIBER OPTIC HOSE
K801592 · EAY
Lares Manufacturing Co., Inc.
Dental · 10d
Cleared Jul 21, 1980
ASPIRATOR
K801620 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 6d
Cleared Jul 18, 1980
ORGANON ARTERIAL BLOOD SAMPLER
K801435 · CBT
Akzona, Inc.
Anesthesiology · 29d
Cleared Jul 14, 1980
LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
K800624 · KPO
Travenol Laboratories, S.A.
Gastroenterology & Urology · 117d
Cleared Jul 14, 1980
AMBULATORY INFUSION PUMP, CODE 2M9807
K800627 · FRN
Travenol Laboratories, S.A.
General Hospital · 117d
Cleared Jul 14, 1980
ANTIBODY TO VARICELLA-ZOSTER VIRUS
K800787 · GGW
Electro-Nucleonics Laboratories, Inc.
Microbiology · 97d
Cleared Jul 14, 1980
DOUCHE UNIT-1500 ML DISP. CONTAINER
K800957 · HED
The Healthcare Group Laboratories, Inc.
Obstetrics & Gynecology · 82d
Cleared Jul 14, 1980
MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.
K801138 · DRS
Gics Pharmaceuticals
Cardiovascular · 63d
Cleared Jul 14, 1980
COBE HEMOFLO BLOOD TUBING SETS
K801211 · FJK
Cobe Laboratories, Inc.
Gastroenterology & Urology · 55d
Cleared Jul 14, 1980
STERILE, DISP DOME, INDIVID. PKG.
K801239 · DRS
Pacific Domes, Inc.
Cardiovascular · 48d
Cleared Jul 14, 1980
WHITE BLOOD CELL COUNT CONTROL LEVELS
K801265 · JPK
Bioscientific
Hematology · 47d
Cleared Jul 14, 1980
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
K801267 · JPK
Bioscientific
Hematology · 47d
Cleared Jul 14, 1980
HEMOGLOBIN CONTROL LEVELS
K801268 · KHG
Bioscientific
Hematology · 47d
Cleared Jul 14, 1980
COBAS CK-NAC REAGENT
K801299 · CGS
Roche Analytical Instruments, Inc.
Chemistry · 42d
Cleared Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318 · JHX
Helena Laboratories
Chemistry · 36d
Cleared Jul 14, 1980
ACUVAC(TM) SUCTION RESERVOIR 400CC AND
K801350 · GCY
Innovative Surgical Products, Inc.
General & Plastic Surgery · 35d
Cleared Jul 14, 1980
CARDIOTOMY RESERVOIR WITH FILTER
K801360 · DTP
Travenol Laboratories, S.A.
Cardiovascular · 35d
Cleared Jul 14, 1980
BECKMAN MODEL 42 SPECTROPHOTOMETER
K801373 · JJQ
Beckman Instruments, Inc.
Chemistry · 34d