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
167785–167808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1980
NEUROMETRICS MONITOR
K800452 · GWS
Neurometrics
Neurology · 34d
Cleared Apr 02, 1980
ADDITIONAL COMPONENTS KRONNER COMPRES
K800502 · HRS
Richard F. Kronner, M.D.
Orthopedic · 29d
Cleared Apr 02, 1980
SERALYZER REFLECTANCE PHOTOMETER/CALIB.
K800524 · CIE
Miles Laboratories, Inc.
Chemistry · 27d
Cleared Apr 02, 1980
SCHLEIN TRI-SURFACE ANKLE
K800530 · HSN
Orthopedic Equipment Co., Inc.
Orthopedic · 26d
Cleared Apr 02, 1980
CINOXACIN 100 MCG SENSI DISC
K800540 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 23d
Cleared Apr 02, 1980
100 ML SNYDER HEMOVAC
K800542 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 23d
Cleared Apr 02, 1980
LIPASE DETERMINATION
K800550 · CFG
The Dow Chemical Co.
Chemistry · 23d
Cleared Apr 02, 1980
KDA MICRO CHEMICAL ANALYZER
K800572 · JJE
American Monitor Corp.
Chemistry · 19d
Cleared Apr 02, 1980
PERCUTANEOUS CATHETER INTRODUCER
K800580 · DYB
Alva Medical, Inc.
Cardiovascular · 19d
Cleared Apr 02, 1980
NSI CREATININE KIT
K800583 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
NSI SODIUM/POTASSIUM KIT
K800584 · JGS
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
NSI CHLORIDE REAGENT KIT
K800585 · JFS
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
CONTOUROGRAPH M-500
K800591 · LDK
Bio-Tek Instruments, Inc.
Physical Medicine · 16d
Cleared Apr 02, 1980
SIRECUST 311S
K800593 · DPS
Siemens Corp.
Cardiovascular · 16d
Cleared Apr 02, 1980
REUSABLE HAND-TROL
K800597 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Apr 02, 1980
ANA LATEX SLIDE TEST
K800605 · DHC
Biologics Intl., Inc.
Microbiology · 16d
Cleared Apr 02, 1980
MEDTEK #411 PORTABLE B-P INSTR.
K800614 · DXN
Med-Tek Corp.
Cardiovascular · 15d
Cleared Apr 02, 1980
TYPE 4000 TRANSCUTANEOUS ELEC. STIM.
K800630 · GZJ
Frye Electronics, Inc.
Neurology · 13d
Cleared Apr 02, 1980
OXYMETER
K800631 · KLK
Dragerwerk AG
Anesthesiology · 13d
Cleared Apr 02, 1980
OHIO DISPOSABLE TRACHEAL TUBE
K800634 · BTR
Ohio Medical Products
Anesthesiology · 12d
Cleared Apr 02, 1980
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K800650 · CBK
Hospal Medical Corp.
Anesthesiology · 9d
Cleared Apr 02, 1980
SURE FLOW TUBING
K800664 · BYX
B & F Medical Products, Inc.
Anesthesiology · 7d
Cleared Apr 02, 1980
FIBERGLASS CYLINDER BASES, #'S 65040-
K800665
B & F Medical Products, Inc.
Cardiovascular · 7d
Cleared Mar 25, 1980
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · DTC
Ela Medical, Inc.
Cardiovascular · 98d