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
56017–56040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2008
MAMMO WORKSTATION
K081630 · LLZ
Image Diagnost International GmbH
Radiology · 48d
Cleared Jul 29, 2008
CONMED BEAMER SYSTEM C600
K081678 · GEI
Kls Martin GmbH + Co. KG
General & Plastic Surgery · 42d
Cleared Jul 29, 2008
RSVP PHANTOM PELVIS, MODEL TLP260
K081760 · IYE
The Phantom Laboratory, Inc.
Radiology · 39d
Cleared Jul 29, 2008
K450 POWERED WHEELCHAIR
K081964 · ITI
Permobil AB
Physical Medicine · 19d
Cleared Jul 28, 2008
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
K073382 · LSE
Focus Diagnostics, Inc.
Microbiology · 238d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · JZO
Roche Diagnostics Corp.
Immunology · 196d
Cleared Jul 28, 2008
VALVULOTOME BY KOVEN
K080178 · MGZ
Koven Technology, Inc.
Cardiovascular · 186d
Cleared Jul 28, 2008
PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY
K080220 · DZI
Italia Medica S.R.L.
Dental · 181d
Cleared Jul 28, 2008
ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD,...
K081129 · GEI
Surgrx, Inc.
General & Plastic Surgery · 98d
Cleared Jul 28, 2008
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081161 · CFN
Dade Behring, Inc.
Immunology · 95d
Cleared Jul 28, 2008
FLOCHANNEL
K081176 · MNR
Chad Therapeutics, Inc.
Anesthesiology · 94d
Cleared Jul 28, 2008
HOMELOX
K081206 · CAW
Respironics, Inc.
Anesthesiology · 90d
Cleared Jul 28, 2008
T-STAT 303 ISCHEMIA MONITORING SYSTEM
K081233 · MUD
Spectros Corporation
Cardiovascular · 88d
Cleared Jul 28, 2008
ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING
K081430 · OLX
Elekta Neuromag OY
Neurology · 68d
Cleared Jul 28, 2008
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS...
K081497 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jul 28, 2008
OSFERION D
K081561 · LYC
Olympus Terumo Biomaterials Corporation
Dental · 55d
Cleared Jul 28, 2008
CLEARFIL SA CEMENT
K081583 · EMA
Kuraray Medical, Inc.
Dental · 53d
Cleared Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · LLZ
Agfa Healthcare Corporation
Radiology · 17d
Cleared Jul 28, 2008
STRYKER SPINE AVS PL PEEK SPACERS
K082014 · MAX
Stryker Corp.
Orthopedic · 13d
Cleared Jul 25, 2008
SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
K073249 · DQA
Solaris Medical Technology, Inc.
Anesthesiology · 249d
Cleared Jul 25, 2008
EPICOR ABLATION SYSTEM
K080292 · OCL
St Jude Medical
Cardiovascular · 172d
Cleared Jul 25, 2008
LIASYS WITH MODELS LIASYS
K080468 · CFR
Ams S.R.L. Analyzer Medical System
Chemistry · 155d
Cleared Jul 25, 2008
RELIEVE LAMINOPLASTY FIXATION SYSTEM
K080664 · NQW
Globus Medical, Inc.
Orthopedic · 137d
Cleared Jul 25, 2008
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
K080848 · DJZ
Q3 Innovations, LLC
Chemistry · 121d