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
53113–53136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2009
STAR 55 MODEL 100
K090172 · MHX
Larsen & Toubro Limited
Cardiovascular · 133d
Cleared Jun 05, 2009
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT,...
K090273 · BZQ
Kai Sensors, Inc.
Anesthesiology · 121d
Cleared Jun 05, 2009
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
K090283 · JIX
Genchem, Inc.
Chemistry · 120d
Cleared Jun 05, 2009
RES-Q INFANT WEDGE AND SLING
K090284 · FRP
Cr Enterprises, LLC
General Hospital · 120d
Cleared Jun 05, 2009
XPI ANGLED ABUTMENTS
K090397 · NHA
Keystone Dental, Inc.
Dental · 108d
Cleared Jun 05, 2009
PLANET 55, MODEL 100
K090443 · MHX
Larsen & Toubro Limited
Cardiovascular · 105d
Cleared CT Jun 05, 2009
PROVOX VEGA, MODEL 8130-8135
K090455 · EWL
Atos Medical AB
Ear, Nose, Throat · 102d
Cleared Jun 05, 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · GZJ
Empi
Neurology · 65d
Cleared Jun 05, 2009
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
K090933 · NJM
Forestadent Bernhard Forster GmbH
Dental · 64d
Cleared Jun 05, 2009
RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK...
K090951 · GXY
Rs Medical
Neurology · 63d
Cleared Jun 05, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971 · LSL
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jun 05, 2009
COVIDIEN EXTENDED TIP APPLICATOR
K091315 · FMF
Confluent Surgical,Inc
General Hospital · 32d
Cleared Jun 05, 2009
RADIA STEERABLE DIAGNOSTIC CATHETER
K091370 · DRF
C.R. Bard, Inc.
Cardiovascular · 28d
Cleared Jun 05, 2009
MP5 INTELLIVUE PATIENT MONITOR
K091395 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 25d
Cleared Jun 05, 2009
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
K091498 · LLZ
Vital Images, Inc.
Radiology · 16d
Cleared Jun 04, 2009
OPTION VENA CAVA FILTER
K081410 · DTK
Rex Medical
Cardiovascular · 380d
Cleared Jun 04, 2009
COLUMBUS REVISION KNEE SYSTEM
K083772 · JWH
Aesculap Implant System, Inc.
Orthopedic · 168d
Cleared Jun 04, 2009
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
K090114 · DYB
Oscor, Inc.
Cardiovascular · 134d
Cleared Jun 04, 2009
REVOLUTION FULL CORE BIOPSY
K090611 · KNW
Inrad
Gastroenterology & Urology · 90d
Cleared Jun 04, 2009
EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
K090629 · NBW
Tyson Bioresearch, Inc.
Chemistry · 87d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,
K090768 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
K090769 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905
K090770 · DXN
Andon Health Co, Ltd.
Cardiovascular · 73d