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
37585–37608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2014
INFX-8000V, V5.30
K133535 · OWB
Toshibamedical Systems Corporation
Radiology · 247d
Cleared Jul 23, 2014
INTELLIJOINT HIP
K133759 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 224d
Cleared Jul 23, 2014
CADWELL SPIKE AND SEIZURE DETECTOR
K140552 · OMB
Cadwell
Neurology · 141d
Cleared Jul 23, 2014
ARTHROSCOPIC ENERGY SYSTEM
K140578 · GEI
Conmed Corporation
General & Plastic Surgery · 139d
Cleared CT Jul 23, 2014
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
K140775 · MCW
Spectranetics Corporation
Cardiovascular · 117d
Cleared Jul 23, 2014
IFUSE IMPLANT SYSTEM
K141049 · OUR
SI-BONE, Inc.
Orthopedic · 91d
Cleared Jul 23, 2014
DYNAMIC NEUROSCREENING DEVICE
K141208 · LQW
Prosenex
Neurology · 75d
Cleared Jul 23, 2014
OKAMOTO STUDDED CONDOM
K141256 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 23, 2014
CASPIAN SPINAL SYSTEM
K141284 · KWP
K2m, Inc.
Orthopedic · 68d
Cleared Jul 23, 2014
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
K141784 · HRS
Ortho Solutions Limited
Orthopedic · 21d
Cleared Jul 22, 2014
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
K130097 · FMI
American Medical Manufacturing, Inc./...
General Hospital · 553d
Cleared Jul 22, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
K131721 · LNS
Comed Medical Systems Co., Ltd.
Gastroenterology & Urology · 405d
Cleared Jul 22, 2014
PICOSURE WORKSTATION
K133364 · GEX
Cynosure, Inc.
General & Plastic Surgery · 263d
Cleared Jul 22, 2014
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP...
K133370 · LPH
Signature Orthopaedics Pty Limited
Orthopedic · 260d
Cleared Jul 22, 2014
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · MJN
Boston Scientific Corp
Cardiovascular · 169d
Cleared Jul 22, 2014
BIO-CONNEKT WOUND MATRIX
K140456 · KGN
MLM Biologics, Inc.
General & Plastic Surgery · 148d
Cleared Jul 22, 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · FRG
STERIS Corporation
General Hospital · 145d
Cleared Jul 22, 2014
VELOXTM INTERBODY FUSION SYSTEM
K140864 · ODP
U&I Corp.
Orthopedic · 110d
Cleared Jul 22, 2014
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
K140876 · HRS
Icon Orthopedic Concepts, LLC Dba...
Orthopedic · 106d
Cleared Jul 22, 2014
OARTRAC SYSTEM
K141154 · NZT
Radiadyne
Radiology · 78d
Cleared Jul 22, 2014
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
K141583 · ONF
Shaser, Inc.
General & Plastic Surgery · 39d
Cleared Jul 22, 2014
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
K141652 · KPS
Cedars-Sinai Medical Center
Radiology · 32d
Cleared Jul 22, 2014
EEVA DISH (WITH 12 MICROWELLS)
K141663 · MQK
Auxogyn, Inc.
Obstetrics & Gynecology · 29d
Cleared Jul 22, 2014
VARIAX ELBOW PLATING SYSTEM
K141677 · HRS
Stryker Trauma AG
Orthopedic · 29d