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
38593–38616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2014
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
K122298 · IZL
Ajex Meditech., Ltd.
Radiology · 605d
Cleared Mar 28, 2014
STERRAD 50/100S/200 TEST PACK
K130263 · FRC
Advanced Sterilization Products
General Hospital · 417d
Cleared Mar 28, 2014
X-RAY TV SYSTEM SONIAL VISION G4
K131075 · JAA
Shimadzu Corp.
Radiology · 345d
Cleared Mar 28, 2014
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
K131861 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 277d
Cleared Mar 28, 2014
I-HIP TOTAL HIP SYSTEM
K132572 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 225d
Cleared Mar 28, 2014
VITAL COUGH
K132988 · NHJ
Lung Assist, Inc.
Anesthesiology · 185d
Cleared Mar 28, 2014
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL...
K133116 · KCT
Conmed Corporation
General Hospital · 179d
Cleared Mar 28, 2014
QUICK JET M
K133170 · EFB
Micron Corp.
Dental · 162d
Cleared Mar 28, 2014
ORTHOSCAN FD MINI C-ARM
K133174 · OXO
Orthoscan, Inc.
Radiology · 162d
Cleared Mar 28, 2014
B&B BUBBLER
K133210 · BYE
S & T Medical Technologies, Inc.
Anesthesiology · 162d
Cleared Mar 28, 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C...
K133344 · LCP
Sebia
Chemistry · 149d
Cleared Mar 28, 2014
NEUROSTAR TMS THERAPY SYSTEM
K133408 · OBP
Neuronetics
Neurology · 142d
Cleared Mar 28, 2014
PEEK FUSION IMPLANT
K133515 · HWC
Mtp Solutions, LLC
Orthopedic · 133d
Cleared Mar 28, 2014
FLOCAP
K133540 · CCK
Maxtec, Inc.
Anesthesiology · 130d
Cleared Mar 28, 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · JWH
Conformis, Inc.
Orthopedic · 128d
Cleared Mar 28, 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · HWC
Extremity Medical, LLC
Orthopedic · 122d
Cleared Mar 28, 2014
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
K133940 · HRY
Biomet UK, Ltd.
Orthopedic · 95d
Cleared Mar 28, 2014
CORONIS 5MP
K133984 · LLZ
Barco N.V.
Radiology · 92d
Cleared Mar 28, 2014
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
K134016 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 88d
Cleared Mar 28, 2014
AXERA 2 ACCESS SYSTEM
K140201 · DYB
Arstasis, Inc.
Cardiovascular · 60d
Cleared Mar 27, 2014
PATHFAST CTNL CALIBRATORS
K130603 · JIT
Mitsubishi Chemical Medience Corporation
Chemistry · 385d
Cleared Mar 27, 2014
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED...
K132002 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 269d
Cleared Mar 27, 2014
BIOMET ACCESS SYSTEM
K132373 · PDQ
Biomet Spine (Aka Ebi, LLC)
Neurology · 240d
Cleared Mar 27, 2014
VENTED MILLEX -GV, CATHIVEX -GV
K133004 · BSN
Merck Millipore , Ltd.
Anesthesiology · 183d