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
137305–137328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1988
RF CARD TEST & RF LIQUID TEST
K880164 · DHR
Ampcor, Inc.
Immunology · 28d
Cleared Feb 10, 1988
GEMINI SURGICAL LIGHT
K880198 · FSS
American Sterilizer Co.
General & Plastic Surgery · 26d
Cleared Feb 10, 1988
SURGICAL BLADES
K880244 · GES
Ailee C/O Havel'S, Inc.
General & Plastic Surgery · 21d
Cleared Feb 10, 1988
THERMAL-PAK MODEL SW 1000
K880252 · LHC
Micro Tek Engineering
General Hospital · 21d
Cleared Feb 09, 1988
CARE TELSTAT MODELS: MP 5010 AND MP 5020
K874844 · DRT
Care Systems, Inc.
Cardiovascular · 77d
Cleared Feb 09, 1988
CALIBRATION REFERENCE PLASMA
K874940 · GGP
Baxter Healthcare Corp
Hematology · 69d
Cleared Feb 09, 1988
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
K875197 · LRX
Pro-Optics, Inc.
Ophthalmic · 54d
Cleared Feb 09, 1988
RETICULOCYTE STAIN
K875310 · KFC
Sigma Diagnostics, Inc.
Pathology · 42d
Cleared Feb 09, 1988
FIBRINOSTICON
K880077 · GHH
Organon Teknika Corp.
Hematology · 29d
Cleared Feb 08, 1988
5 MHZ DOPPLER OUTRIGGER
K872817 · IYN
Philips Ultrasound, Inc.
Radiology · 207d
Cleared Feb 08, 1988
STARKEY MODEL P1 MODULE
K873031 · LRB
Starkey Laboratories, Inc.
Ear, Nose, Throat · 188d
Cleared Feb 08, 1988
KODAK SURECELL(TM) HCG-URINE KIT
K874388 · JHI
Eastman Kodak Company
Chemistry · 104d
Cleared Feb 08, 1988
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · FFX
Mentor Corp.
Gastroenterology & Urology · 84d
Cleared Feb 08, 1988
DIAMOND MEDICAL, INC. MODEL DM 800
K874709 · FFT
Diamond Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 08, 1988
DIAMOND MEDICAL, INC. MODEL DM 600
K874710 · FFT
Diamond Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 08, 1988
TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
K874774 · LHX
Vinyl Technology, Inc.
Anesthesiology · 81d
Cleared Feb 08, 1988
LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL
K874821 · EJS
Deringer-Ney, Inc.
Dental · 76d
Cleared Feb 08, 1988
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
K874857 · JJE
Eastman Kodak Company
Chemistry · 75d
Cleared Feb 08, 1988
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944 · EBC
Dentsply Intl.
Dental · 66d
Cleared Feb 08, 1988
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE
K875084 · HHK
Cabot Medical Corp.
Obstetrics & Gynecology · 61d
Cleared Feb 08, 1988
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263 · JGS
Technicon Instruments Corp.
Chemistry · 48d
Cleared Feb 05, 1988
RADIALLY-SUPPORTED VASCULAR PROSTHESES
K870884 · DSY
Intervascular, Inc.
Cardiovascular · 337d
Cleared Feb 05, 1988
MEDRAD MRI INJECTION SYSTEM
K873173 · DXT
Medrad, Inc.
Cardiovascular · 177d
Cleared Feb 05, 1988
LEVTECH COMPOSITE TRACTION TONGS
K873693 · HAX
Levtech, Inc.
Neurology · 144d