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

Filters: Cleared only ×
176,076 results
74905–74928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2002
DAYTRIPPER DIALYSATE WARMER
K020542 · MLW
Stickman Industries, Inc.
Gastroenterology & Urology · 220d
Cleared Sep 27, 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
K021266 · KNS
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 158d
Cleared Sep 27, 2002
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K021793 · LSE
Pan Bio Pty. , Ltd.
Microbiology · 119d
Cleared Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021814 · MMI
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Sep 27, 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103 · BZG
Puritan Bennett Corp.
Anesthesiology · 91d
Cleared Sep 27, 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
K022115 · DTZ
Terumo Corp.
Cardiovascular · 88d
Cleared Sep 27, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K022297 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 73d
Cleared Sep 27, 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162,...
K022424 · DZE
Nobel Biocare Uas, Inc.
Dental · 65d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cook, Inc.
Cardiovascular · 56d
Cleared Sep 27, 2002
M2 SINGLE USE MICROKERTOME
K022560 · HMY
Moria SA
Ophthalmic · 56d
Cleared Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
K022851 · JJY
Quidel Corp.
Chemistry · 31d
Cleared Sep 27, 2002
HRK-63 KNEE ARRAY COIL
K022883 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
K022901 · JIS
Ortho-Clinical Diagnostics
Chemistry · 24d
Cleared Sep 26, 2002
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
K020457 · HRX
Axiamed, Inc.
Orthopedic · 227d
Cleared Sep 26, 2002
DOCXS B SERIES ELECTRODES
K020903 · GXY
Docxs, LLC
Neurology · 190d
Cleared Sep 26, 2002
CHLORAPREP
K021131 · LBH
Centrix, Inc.
Dental · 171d
Cleared Sep 26, 2002
ATLAS MONITOR, MODELS 200,210,220
K022084 · DQA
Welch Allyn, Inc.
Anesthesiology · 91d
Cleared Sep 26, 2002
AUTO*THERM 395, MODEL ME 395
K022458 · IMJ
Mettler Electronics Corp.
Physical Medicine · 62d
Cleared Sep 26, 2002
PULPDENT PUTTY DAM
K022522 · EIE
Pulpdent Corporation
Dental · 58d
Cleared Sep 26, 2002
CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE...
K022792 · LYY
Seal Polymer Industries Bhd.
General Hospital · 35d
Cleared Sep 26, 2002
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA...
K023020 · IXA
Agfa Corp.
Radiology · 15d
Cleared Sep 26, 2002
TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
K023024 · ITX
Vascular Control Systems, Inc.
Radiology · 15d
Cleared Sep 26, 2002
MICRORUPTER V
K023045 · LXS
Meridian AG
Ophthalmic · 14d
Cleared Sep 26, 2002
REPLACE TIUNITE ENDOSSEOUS IMPLANT
K023113 · DZE
Nobel Biocare Uas, Inc.
Dental · 7d