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
34537–34560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2015
PROW FUSION
K151654 · MAX
Nlt Spine, Ltd.
Orthopedic · 29d
Cleared Jul 17, 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase...
K151659 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Jul 17, 2015
IntelliVue Patient Monitor
K151681 · DSI
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 25d
Cleared Jul 17, 2015
GUA60A, GU60A-65
K151685 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Jul 17, 2015
Hi-Light Diagnostic Ultrasound Systems
K151709 · IYO
Qingdao Hisense Medical Equipment...
Radiology · 23d
Cleared Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
K142965 · OEO
Ventana Medical Systems, Inc.
Pathology · 275d
Cleared Jul 16, 2015
2014 InterActive/SwishActive System
K143011 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 269d
Cleared Jul 16, 2015
PROPENCIL Smoke Pencil
K143103 · GEI
Bio Protech, Inc.
General & Plastic Surgery · 260d
Cleared Jul 16, 2015
GC Ortho Connect, GC Ortho Etching Gel
K150128 · DYH
Gc Orthodontics America, Inc.
Dental · 177d
Cleared Jul 16, 2015
Refobacin Bone Cement R
K150850 · MBB
Biomet, Inc.
Orthopedic · 107d
Cleared Jul 16, 2015
Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
K150953 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 98d
Cleared Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 59d
Cleared Jul 16, 2015
ActiveCare+SFT
K151377 · JOW
Medical Compression System (Dbn) , Ltd.
Cardiovascular · 55d
Cleared Jul 16, 2015
Uncoated Tubing and Connector Components
K151523 · DWF
Medtronic, Inc.
Cardiovascular · 41d
Cleared Jul 16, 2015
EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine...
K151557 · DNK
Nantong Egens Biotech Co., Ltd.
Toxicology · 36d
Cleared Jul 16, 2015
MultiFIX S Knotless Fixation System
K151660 · MBI
ArthroCare Corporation
Orthopedic · 27d
Cleared Jul 16, 2015
Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
K151690 · OOI
Alere Scarborough, Inc.
Microbiology · 23d
Cleared Jul 15, 2015
The VersaJet II Hydrosurgery System
K143115 · FQH
Smith & Nephew, Inc.
General Hospital · 258d
Cleared Jul 15, 2015
BA400 14mm Abutment
K150555 · MAH
Cochlear Americas
Ear, Nose, Throat · 133d
Cleared Jul 15, 2015
MedSource ClearSafe Safety IV Catheter
K150611 · FOZ
Medsource International
General Hospital · 127d
Cleared Jul 15, 2015
ACP 1 Anterior Cervical Plating System
K150700 · KWQ
Stryker Corporation
Orthopedic · 119d
Cleared Jul 15, 2015
ILUMIEN OPTIS
K150878 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 105d
Cleared Jul 15, 2015
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR,...
K150903 · MQX
Maanshan Bond Medical Instruments...
General Hospital · 103d
Cleared Jul 15, 2015
OsteoMed Cannulated Screw System
K151021 · HWC
Osteomed Corp.
Orthopedic · 90d