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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
140593–140616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1987
OPN XII UL
K871179 · ILY
Aragona AB Co.
Physical Medicine · 20d
Cleared Apr 13, 1987
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT
K871211 · JLS
Biotecx Laboratories, Inc.
Chemistry · 18d
Cleared Apr 13, 1987
HOOD ESOPHAGEAL PROSTHESIS
K871244 · ESW
Hood Laboratories
Gastroenterology & Urology · 17d
Cleared Apr 13, 1987
CHOLESTEROL DETERMINATION
K871260 · CHH
Biochemical Trade, Inc.
Chemistry · 13d
Cleared Apr 13, 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · JFJ
Technicon Instruments Corp.
Chemistry · 13d
Cleared Apr 10, 1987
HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER
K861505 · DXG
American Medical Equipment, Inc.
Cardiovascular · 352d
Cleared Apr 10, 1987
DOC'S PROPLUGS EAR PLUGS
K862045 · EWD
Doc'S Proplugs, Inc.
Ear, Nose, Throat · 317d
Cleared Apr 10, 1987
DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
K864370 · GZJ
Dynatronics Laser Corp.
Neurology · 156d
Cleared Apr 10, 1987
POS-T-VAC
K864833 · LKY
Ekc, Inc.
Gastroenterology & Urology · 122d
Cleared Apr 10, 1987
ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
K864887 · GEX
Bio Quantum Technologies, Inc.
General & Plastic Surgery · 119d
Cleared Apr 10, 1987
MODEL 6110B DENTAPHOR
K870118 · EAT
Life-Tech Intl., Inc.
Dental · 88d
Cleared Apr 10, 1987
FIBRE OPTIC STRIP CHART RECORDER
K870119 · DSF
Apex Imaging Corp.
Cardiovascular · 88d
Cleared Apr 10, 1987
NEUROMAPPER 1620
K870263 · GWQ
Neuroscience, Inc.
Neurology · 77d
Cleared Apr 10, 1987
MODIFIED HR-3000 REUSE ADAPTOR
K870471 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 66d
Cleared Apr 10, 1987
0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE
K870517 · GEX
Coherent Medical Group
General & Plastic Surgery · 64d
Cleared Apr 10, 1987
EZ TAC FILTER
K870531 · EXB
John F. Greer Co., Inc.
Gastroenterology & Urology · 63d
Cleared Apr 10, 1987
TONOMITOR(TM)
K870606 · FFT
Tonometrics Holdings SA C/O Mackeen...
Gastroenterology & Urology · 58d
Cleared Apr 10, 1987
HEART*AID 1000
K870622 · MKJ
Cardiac Resucitator Corp.
Cardiovascular · 57d
Cleared Apr 10, 1987
HR-3000 REUSE ADAPTOR
K870689 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 10, 1987
SURGICAL STARTER KIT
K870744
Devon Industries, Inc.
General & Plastic Surgery · 44d
Cleared Apr 10, 1987
7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
K870748 · ITX
Philips Ultrasound, Inc.
Radiology · 44d
Cleared Apr 10, 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873 · DRX
Lectec Corp.
Cardiovascular · 38d
Cleared Apr 10, 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · FSM
Medsurg Industries, Inc.
General & Plastic Surgery · 36d
Cleared Apr 10, 1987
MEDSURG BONE MARROW BIOPSY/ASPIRATION TRAY
K870894
Medsurg Industries, Inc.
General & Plastic Surgery · 36d