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
47713–47736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2011
VICOR PD2I ANALYZER
K101867 · DPS
Vicor Technologies, Inc.
Cardiovascular · 286d
Cleared Apr 14, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K102085 · LYZ
Shijiazhuang Glory Plastic Co., Ltd.
General Hospital · 262d
Cleared Apr 14, 2011
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
K102847 · HHK
Jiangsu Suyun Medical Materials Co.,...
Obstetrics & Gynecology · 197d
Cleared Apr 14, 2011
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
K103582 · GXN
Kelyniam Global, Inc.
Neurology · 127d
Cleared Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · OLO
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Apr 14, 2011
EVERCROSS 0.035 OTW PTA DILATATION CATHETER
K110319 · LIT
Ev3, Inc.
Cardiovascular · 70d
Cleared Apr 14, 2011
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K110368 · MQV
Novabone Products, LLC
Orthopedic · 65d
Cleared Apr 14, 2011
OPTERTRAK LOGIC PSC TIBIAL INSERT
K110547 · JWH
Exactech Sarasota
Orthopedic · 48d
Cleared Apr 14, 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K110705 · MNR
Advanced Brain Monitoring, Inc.
Anesthesiology · 31d
Cleared Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K110887 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Apr 13, 2011
STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0...
K101201 · DZE
Kat Implants, LLC
Dental · 349d
Cleared Apr 13, 2011
EVA TPN BAG
K101412 · KPE
Valmed S.R.L.
General Hospital · 328d
Cleared Apr 13, 2011
ODRC-DYNAMIC HIP SCREW SYSTEM
K103015 · KTT
Orthopaedic Device Research Center
Orthopedic · 183d
Cleared Apr 13, 2011
MPS450 MULTIPARAMETER SIMULATOR
K103336 · DRT
Fluke Biomedical
Cardiovascular · 149d
Cleared Apr 13, 2011
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT...
K103556 · EIH
Ivoclar Vivadent, Inc.
Dental · 132d
Cleared Apr 13, 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103784 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 107d
Cleared Apr 13, 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103795 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 107d
Cleared Apr 13, 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 75d
Cleared Apr 13, 2011
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
K110742 · MKJ
ZOLL Medical Corporation
Cardiovascular · 27d
Cleared Apr 12, 2011
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI...
K100321 · LTK
Siemens Healthcare Diagnostics
Immunology · 432d
Cleared Apr 12, 2011
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
K102943 · FRO
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 190d
Cleared Apr 12, 2011
PROPEP DELIVERY DEVICE
K103200 · FMF
Rhythmlink International, LLC
General Hospital · 162d
Cleared Apr 12, 2011
MEDVOXEL HEARTPRO SOFTWARE APPLICATION
K103565 · LLZ
Medvoxel Systems, Inc.
Radiology · 127d
Cleared Apr 12, 2011
INFUSION ADAPTER C100
K110023 · LHI
Carmel Pharma Ab.
General Hospital · 99d