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
44809–44832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2012
CRAG LATERAL FLOW ASSAY (LFA)
K112422 · GMD
Immuno-Mycologics, Inc.
Microbiology · 218d
Cleared Mar 28, 2012
BD RECYKLEEN SHARPS COLLECTORS
K112774 · MMK
Becton, Dickinson and Company
General Hospital · 187d
Cleared Mar 28, 2012
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY...
K112834 · JIX
Verichem Laboratories, Inc.
Chemistry · 182d
Cleared Mar 28, 2012
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
K112948 · IOR
Jiangsu Healthy Way Medical Equipment...
Physical Medicine · 176d
Cleared Mar 28, 2012
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
K112950 · IOR
Jiangsu Healthy Medical Equipment Co;Ltd
Physical Medicine · 176d
Cleared Mar 28, 2012
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243 · LFR
Eps Bio Technology Corp.
Chemistry · 147d
Cleared Mar 28, 2012
REXIOUS HOOK FIXATION SYSTEMS
K113324 · KWP
Dio Medical Co., Ltd.
Orthopedic · 139d
Cleared Mar 28, 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS...
K113547 · CGA
Apex BioTechnology Corp.
Chemistry · 118d
Cleared Mar 28, 2012
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
K113695 · HSB
Ellipse Technologies, Inc.
Orthopedic · 103d
Cleared Mar 28, 2012
FOTONA XP ND: YAG LASER SYSTEM
K113702 · PDZ
Fotona D.D.
General & Plastic Surgery · 103d
Cleared Mar 28, 2012
AQUASHIELD CO2 SYSTEM
K120123 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 28, 2012
ZAVATION IBF SYSTEM
K120576 · MAX
Zavation, LLC
Orthopedic · 30d
Cleared Mar 28, 2012
AZUR DETACHABLE 18
K120630 · KRD
MicroVention, Inc.
Cardiovascular · 27d
Cleared Mar 27, 2012
SURGICASE GUIDE
K111558 · HAW
Materialise NV
Neurology · 298d
Cleared Mar 27, 2012
ABACUS 5
K112755 · GKZ
Diatron U.S., Inc.
Hematology · 188d
Cleared Mar 27, 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III...
K112977 · MSS
Alcon Research, Ltd.
Ophthalmic · 173d
Cleared Mar 27, 2012
ANESTHESIA INJECTION TOOL SET
K113247 · EJI
Ki Works Co., Ltd.
Dental · 146d
Cleared Mar 27, 2012
ZIMMER PERSONA KNEE SYSTEM
K113369 · JWH
Zimmer, Inc.
Orthopedic · 133d
Cleared Mar 27, 2012
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K113672 · MUH
VATECH Co., Ltd.
Radiology · 105d
Cleared Mar 27, 2012
RESSCAN
K113815 · MNS
Resmed, Ltd.
Anesthesiology · 95d
Cleared Mar 27, 2012
WOUND PROTECTOR
K120061 · GCJ
Covidien, Formerly US Surgical A...
General Hospital · 78d
Cleared Mar 27, 2012
MULTIFIX P KNOTLESS FIXATION DEVICE
K120096 · MBI
ArthroCare Corporation
Orthopedic · 75d
Cleared Mar 27, 2012
INDEPENDENCE SPACER
K120101 · OVD
Globus Medical, Inc.
Orthopedic · 75d
Cleared Mar 27, 2012
INSULATION TESTER
K120416 · GEI
Spectrum Surgical Supply Corp.
General & Plastic Surgery · 46d