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

Filters: Cleared only ×
176,076 results
58465–58488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2007
SUCTION COAGULATOR
K072559 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 24d
Cleared Oct 05, 2007
MODIFICATION TO OASYS SYSTEM
K072568 · KWP
Stryker Spine
Orthopedic · 23d
Cleared Oct 05, 2007
PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS
K072572 · NHA
Lifecore Biomedical, Inc.
Dental · 23d
Cleared Oct 05, 2007
KII TROCAR SYSTEM
K072674 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 14d
Cleared Oct 05, 2007
ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT,...
K072699 · GEI
Alma Lasers , Ltd.
General & Plastic Surgery · 11d
Cleared Oct 05, 2007
CSCS-001A CALCIUM SCORING PACKAGE
K072737 · JAK
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 04, 2007
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
K062297 · MLR
STERIS Corporation
General Hospital · 423d
Cleared Oct 04, 2007
RADIUS SNARE
K070502 · DQY
Radius Medical Technologies, Inc.
Cardiovascular · 225d
Cleared Oct 04, 2007
ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS
K070798 · DXT
Coeur, Inc.
Cardiovascular · 195d
Cleared Oct 04, 2007
SCANVIEW, MODEL SC-300
K071398 · JOY
Applied Spectral Imaging , Ltd.
Hematology · 136d
Cleared Oct 04, 2007
PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K071421 · FPA
Promepla
General Hospital · 135d
Cleared Oct 04, 2007
PNEUPAC VR1 AIR MIX
K071527 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 122d
Cleared Oct 04, 2007
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
K071681 · GKZ
Beckman Coulter, Inc.
Hematology · 107d
Cleared Oct 04, 2007
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
K071740 · LZA
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 99d
Cleared Oct 04, 2007
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL...
K072024 · FJK
Nipro Medical Corp.
Gastroenterology & Urology · 72d
Cleared Oct 04, 2007
POWRSYRINGE ASPIRATOR
K072299 · FMF
Pinyons Medical Technology, Inc.
General Hospital · 48d
Cleared Oct 04, 2007
NIKO CORPECTOMY SPACER
K072465 · MQP
Globus Medical, Inc.
Orthopedic · 30d
Cleared Oct 04, 2007
ENDOWAVE INFUSION SYSTEM
K072507 · QEY
Ekos Corp.
Cardiovascular · 28d
Cleared Oct 04, 2007
TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16,...
K072589 · DZE
Zimmer Dental, Inc.
Dental · 20d
Cleared Oct 03, 2007
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
K070296 · GEX
Ace Vision Group
General & Plastic Surgery · 245d
Cleared Oct 03, 2007
E3-80 PORTABLE ECG RECORDER & ANALYZER
K071085 · MWJ
Micro-Star International Co., Ltd.
Cardiovascular · 169d
Cleared Oct 03, 2007
APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
K071230 · MNR
Advanced Brain Monitoring, Inc.
Anesthesiology · 153d
Cleared Oct 03, 2007
INOMAX DS
K071516 · MRN
Ino Therapeutics, LLC
Anesthesiology · 121d
Cleared Oct 03, 2007
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
K071580 · CIT
Thermofisher Scientific OY
Chemistry · 117d