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
32689–32712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 94d
Cleared Mar 03, 2016
Dunamis Force DFX Tensile Tape
K153746 · GAT
Dunamis, LLC
General & Plastic Surgery · 65d
Cleared Mar 03, 2016
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL...
K160276 · GKP
Instrumentation Laboratory CO
Hematology · 30d
Cleared Mar 03, 2016
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
K160347 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 24d
Cleared Mar 02, 2016
Finger Type Pulse Oximeter
K151024 · DQA
Taidoc Technology Corporation
Anesthesiology · 321d
Cleared Mar 02, 2016
BEAUTIFIL II Gingiva
K151700 · EBF
Shofu Dental Corporation
Dental · 252d
Cleared Mar 02, 2016
RECON system - Compression Screws
K151708 · HWC
Normed Medizin-Technik GmbH
Orthopedic · 252d
Cleared Mar 02, 2016
Pencylcap
K152050 · FMI
B.Braun Melsungen AG
General Hospital · 223d
Cleared CT Mar 02, 2016
BioPhotas Celluma3
K152280 · ILY
Biophotas, Inc.
Physical Medicine · 203d
Cleared Mar 02, 2016
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
K152558 · HAW
Elekta Instrument AB
Neurology · 175d
Cleared Mar 02, 2016
Sentimag System, Sentimark Magnetic Marker Systerm
K153044 · PBY
Endomagnetics Ltd.,
General & Plastic Surgery · 135d
Cleared Mar 02, 2016
Baha 5 Super Power Sound Processor
K153245 · LXB
Cochlear Americas
Ear, Nose, Throat · 114d
Cleared Mar 02, 2016
PERIMETER C (Titanium) Spinal System
K153438 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 96d
Cleared Mar 02, 2016
PicoWay Laser System
K153527 · GEX
Syneron Candela Corporation
General & Plastic Surgery · 84d
Cleared Mar 02, 2016
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
K160020 · MNH
Captiva Spine
Orthopedic · 57d
Cleared Mar 02, 2016
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 30d
Cleared CT Mar 01, 2016
xevonta dialyzer
K143482 · KDI
B. Braun Avitum AG
Gastroenterology & Urology · 449d
Cleared Mar 01, 2016
SPINAUT-E, SPINAUT-I
K150789 · BSO
Imedicom Co., Ltd.
Anesthesiology · 342d
Cleared Mar 01, 2016
3400E series
K151905 · LEJ
Heartland Tanning, Inc.
General & Plastic Surgery · 232d
Cleared Mar 01, 2016
iFuse Implant System(R)
K152681 · OUR
SI-BONE, Inc.
Orthopedic · 165d
Cleared Mar 01, 2016
Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves
K152719 · LYZ
Xinfu Medical Products Co., Ltd.
General Hospital · 162d
Cleared Mar 01, 2016
Braun Thermoscan PRO 6000 Ear Thermometer
K152748 · FLL
Kaz USA, Inc (A Subsidiary of Helen...
General Hospital · 160d
Cleared Mar 01, 2016
OrthAlign Plus System
K153237 · OLO
Orthalign, Inc.
Orthopedic · 113d
Cleared Mar 01, 2016
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
K153460 · MCW
Avinger, Inc.
Cardiovascular · 91d