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
75673–75696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 22d
Cleared Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · CFN
The Binding Site, Ltd.
Immunology · 20d
Cleared Jul 16, 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · DPS
Cambridge Heart, Inc.
Cardiovascular · 14d
Cleared Jul 16, 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K022152 · DPS
Cambridge Heart, Inc.
Cardiovascular · 14d
Cleared Jul 15, 2002
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 342d
Cleared Jul 15, 2002
ARM AUTOMATIC REPROCESSING MACHINE
K013713 · LIF
Alcavis International Incorporated
Gastroenterology & Urology · 249d
Cleared Jul 15, 2002
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
K020968 · JHI
Pan Probe Biotech, Inc.
Chemistry · 111d
Cleared Jul 15, 2002
EMT-CPAP
K021520 · BTL
Emergency Medical Techology
Anesthesiology · 66d
Cleared Jul 15, 2002
PHFW-10
K021592 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 61d
Cleared Jul 15, 2002
SPI ONETIME DENTAL IMPLANT
K022038 · DZE
Paxmed International
Dental · 21d
Cleared Jul 13, 2002
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
K020585 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 141d
Cleared Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151 · JIF
Bayer Diagnostics Corp.
Chemistry · 94d
Cleared Jul 13, 2002
ULTRAQUIET
K021202 · KLW
Sound Technique System, LLC
Ear, Nose, Throat · 88d
Cleared Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · KXK
Cp Medical
Radiology · 79d
Cleared Jul 13, 2002
BACTEC MGIT 960 PZA KIT
K021582 · MJA
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jul 12, 2002
MEDX 1000 SERIES
K020017 · ILY
Medx Electronics, Inc.
Physical Medicine · 190d
Cleared Jul 12, 2002
MEDICAL ADMINISTRATOR
K020073 · LLZ
Barco N.V.
Radiology · 184d
Cleared Jul 12, 2002
3D KNEE
K020114 · JWH
Encore Orthopedics, Inc.
Orthopedic · 182d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · LCD
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Jul 12, 2002
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
K020735 · GXY
Cathay International, Ltd.
Neurology · 128d
Cleared Jul 12, 2002
EXTENSION SET, MODELS 1911-512
K020926 · FPA
Epimed International, Inc.
General Hospital · 113d
Cleared Jul 12, 2002
MECHANICAL DAILY USE WHEELCHAIR
K021075 · IOR
First World Services, Inc.
Physical Medicine · 101d
Cleared Jul 12, 2002
NERVUS MONITOR
K021185 · OLV
Taugagreining HF
Neurology · 88d
Cleared Jul 12, 2002
AUTOALIGN
K021191 · LLZ
Cortechs Labs, Inc.
Radiology · 88d