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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
57841–57864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2007
SCANORA 3D
K073350 · MUH
Soredex Palodex Group OY
Radiology · 20d
Cleared Dec 19, 2007
PROPLATE
K073360 · GEI
Bio Protech, Inc.
General & Plastic Surgery · 19d
Cleared Dec 19, 2007
GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
K073408 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 15d
Cleared Dec 19, 2007
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423 · LJT
C.R. Bard, Inc.
General Hospital · 14d
Cleared Dec 18, 2007
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · DXQ
Welch Allyn, Inc.
Cardiovascular · 347d
Cleared Dec 18, 2007
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K070356 · NEY
Medwaves Incorporated
General & Plastic Surgery · 315d
Cleared Dec 18, 2007
STERRAD 100NX TEST PACK
K071537 · FRC
Advanced Sterilization Products
General Hospital · 196d
Cleared Dec 18, 2007
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE...
K071930 · LCX
Blue Cross Bio-Medical Co., Ltd.
Chemistry · 158d
Cleared Dec 18, 2007
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K071995 · DSI
Card Guard Scientific Survival , Ltd.
Cardiovascular · 151d
Cleared Dec 18, 2007
EMS PIEZON MASTER SURGERY
K072146 · DZI
E.M.S Electro Medical Systems S.A
Dental · 137d
Cleared Dec 18, 2007
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
K072180 · FAJ
Vision-Sciences, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 18, 2007
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
K072271 · HAW
Stryker Corp.
Neurology · 125d
Cleared Dec 18, 2007
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM
K072537 · MQP
Creaspine Sas
Orthopedic · 99d
Cleared Dec 18, 2007
PERFORMAX SE TOTAL FACE MASK
K072588 · CBK
Respironics Inc., Sleep & Home...
Anesthesiology · 95d
Cleared Dec 18, 2007
ACUSON X300 ULTRASOUND SYSTEM
K072676 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Dec 18, 2007
SYNTHES (USA) 2.0MM TITANIUM T-PLATE
K072758 · GWO
Synthes (Usa)
Neurology · 81d
Cleared Dec 18, 2007
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065,...
K072796 · DQO
Concentric Medical, Inc.
Cardiovascular · 78d
Cleared Dec 18, 2007
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
K072995 · GEX
Lumen Development and Manufacturing,...
General & Plastic Surgery · 56d
Cleared Dec 18, 2007
IDRIVES, IDRIVEC, IDRIVEF
K073001 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 55d
Cleared Dec 18, 2007
SAPPHIRE CERAMIC BRACKET
K073045 · NJM
Ortho Technology, Inc.
Dental · 50d
Cleared Dec 18, 2007
GE LOGIQ P6
K073297 · IYN
General Electric Co.
Radiology · 25d
Cleared Dec 18, 2007
SYNGO VOLUME PERFUSION-CT BODY
K073373 · JAK
Siemens AG Medical Solutions
Radiology · 15d
Cleared Dec 17, 2007
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
K071679 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 181d
Cleared Dec 17, 2007
CROSS.BONE
K071876 · MQV
TriMed, Inc.
Orthopedic · 164d