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

Filters: Cleared only ×
175,820 results
30577–30600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2016
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage
K162220 · ODP
Dio Medical Co., Ltd.
Orthopedic · 105d
Cleared Nov 21, 2016
OptiLux LED Illuminator
K163185 · HBI
Isolux, LLC
General & Plastic Surgery · 7d
Cleared Nov 18, 2016
Quest Diagnostics HairCheck-DT (Cocaine)
K152232 · DIO
Quest Diagnostics Incorporated
Toxicology · 469d
Cleared Nov 18, 2016
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K153394 · DFH
Diazyme Laboratories
Immunology · 360d
Cleared Nov 18, 2016
RAPIDO HOLLOW-FIBRE DIALYZERS
K160558 · KDI
Bellco Srl
Gastroenterology & Urology · 263d
Cleared Nov 18, 2016
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical...
K160595 · FRG
Pms Medikal Ambalaj Sanayi VE Ticaret...
General Hospital · 262d
Cleared Nov 18, 2016
Discovery NM 750b Bopsy
K160933 · IYX
Ge Healthcare
Radiology · 228d
Cleared Nov 18, 2016
Walk-O2-Bout
K161472 · ECX
Essex Industries, Inc.
Anesthesiology · 175d
Cleared Nov 18, 2016
LacriPro Punctum Plug
K161673 · LZU
Lacrimedics, Inc.
Ophthalmic · 155d
Cleared Nov 18, 2016
MAGNETOM ESSENZA
K161795 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Nov 18, 2016
EVOS Small Fragment Plating System
K162078 · HRS
Smith & Nephew, Inc.
Orthopedic · 114d
Cleared Nov 18, 2016
Preference Elite Pedicle Screw System
K162160 · NKB
Amedica Corporation
Orthopedic · 108d
Cleared Nov 18, 2016
GFS Ultimate
K162198 · MBI
Parcus Medical, LLC
Orthopedic · 105d
Cleared Nov 18, 2016
Fully Automatic Electronic Blood Pressure Monitor
K162230 · DXN
Adon Health Co., Ltd.
Cardiovascular · 102d
Cleared Nov 18, 2016
V30 system, V-Form Handpiece BC Medium applicator
K162363 · GEX
Viora , Ltd.
General & Plastic Surgery · 87d
Cleared Nov 18, 2016
HyperBand
K162403 · LNH
Ge Medical Systems, LLC
Radiology · 81d
Cleared Nov 18, 2016
Dosimetry Check Version 5 Release 1
K162577 · IYE
Math Resolutions, LLC
Radiology · 64d
Cleared Nov 18, 2016
Capillus302, Capillus312, Capillus352
K162994 · OAP
Capillus, LLC
General & Plastic Surgery · 22d
Cleared Nov 17, 2016
Heyman Packing Applicator Set
K160045 · JAQ
Varian Medical Systems, Inc.
Radiology · 314d
Cleared Nov 17, 2016
TroClose1200
K160564 · GAM
Gordian Surgical, Ltd.
General & Plastic Surgery · 262d
Cleared CT Nov 17, 2016
CONTOUR NEXT ONE Blood Glucose Monitoring System
K160682 · NBW
Ascensia Diabetes Care
Chemistry · 252d
Cleared Nov 17, 2016
REDAPT Anteverted Cemented Liner
K160923 · JDI
Smith & Nephew, Inc.
Orthopedic · 227d
Cleared Nov 17, 2016
Xsert Lumbar Expandable Interbody System
K160959 · MAX
X-Spine Systems, Inc.
Orthopedic · 226d
Cleared Nov 17, 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074 · LZA
Shen Wei (Usa), Inc.
General Hospital · 213d