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
36265–36288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2014
Full Automatic (NIBP) Blood Pressure Monitor
K142968 · DXN
Health & Life Co., Ltd.
Cardiovascular · 66d
Cleared Dec 19, 2014
CPX Control Breast Tissue Expander
K142998 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 63d
Cleared Dec 19, 2014
Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)
K143161 · GEI
Covidien
General & Plastic Surgery · 46d
Cleared Dec 19, 2014
TrueBeam-TrueBeam STx-Edge
K143224 · IYE
Varian Medical Systems, Inc.
Radiology · 39d
Cleared Dec 19, 2014
Reform Pedicle Screw System
K143248 · NKB
Precision Spine, Inc.
Orthopedic · 37d
Cleared Dec 19, 2014
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix...
K143328 · MCW
Volcano Atheromed, Inc.
Cardiovascular · 29d
Cleared Dec 19, 2014
Mini me
K143339 · ONF
Iluminage Ltd.(Formerly Syneron...
General & Plastic Surgery · 29d
Cleared Dec 19, 2014
Elecsys T-Uptake Calset
K143342 · JIT
Roche Diagnostics
Chemistry · 28d
Cleared Dec 18, 2014
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS,...
K133047 · LAF
Biophor Diagnostics, Inc.
Chemistry · 447d
Cleared Dec 18, 2014
RAPID-I KIT
K140207 · MQK
Vitrolife Sweden AB
Obstetrics & Gynecology · 324d
Cleared Dec 18, 2014
DISPOSABLE TRACHEAL TUBE
K140228 · BTR
Suzhou Weikang Medical Apparatus Co.,...
Anesthesiology · 322d
Cleared Dec 18, 2014
ARTHREX SUTURETAK SUTURE ANCHORS
K140855 · MAI
Arthrex, Inc.
Orthopedic · 259d
Cleared Dec 18, 2014
OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
K140978 · JEY
Osteomed
Dental · 246d
Cleared Dec 18, 2014
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
K141214 · CAF
Teleflexmedical, Inc.
Anesthesiology · 220d
Cleared Dec 18, 2014
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM
K141218 · DQX
Vadiswire Corporation
Cardiovascular · 220d
Cleared Dec 18, 2014
FASTFORWARD
K141420 · HTN
MedShape, Inc.
Orthopedic · 203d
Cleared Dec 18, 2014
BECTON DICKINSON INTELLIPORT SYSTEM
K141474 · PHC
Becton, Dickinson & CO
General Hospital · 198d
Cleared CT Dec 18, 2014
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · DXX
Stereotaxis, Inc.
Cardiovascular · 192d
Cleared Dec 18, 2014
KIMGUARD ONE STEP STERILIZATION WRAP
K141712 · FRG
Halyard Health
General Hospital · 176d
Cleared Dec 18, 2014
DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD...
K141727 · EIH
Liaoning Upcera Co., Ltd.
Dental · 175d
Cleared Dec 18, 2014
TRISTAR BONE GRAFT FIXATION SYSTEM
K141764 · JEY
Impladent , Ltd.
Dental · 170d
Cleared Dec 18, 2014
VIBRANCE KEGEL DEVICE (VKD)
K141893 · HIR
Bioinfinity (M) Sdn. Bhd.
Gastroenterology & Urology · 157d
Cleared Dec 18, 2014
INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA
K142043 · EIH
Jensen Industries, Inc.
Dental · 143d
Cleared Dec 18, 2014
MULTIX FUSION VA30 & VA40
K142049 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 143d