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
51961–51984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2009
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT...
K092381 · HRS
Ibalance Medical, Inc.
Orthopedic · 83d
Cleared Oct 27, 2009
REVERSE SHOULDER PROSTHESIS
K092873 · PHX
Djo Surgical
Orthopedic · 39d
Cleared Oct 27, 2009
ACACIA PISTON SYRINGE
K092986 · FMF
Acacia, Inc.
General Hospital · 29d
Cleared Oct 26, 2009
ULC SPINAL PEDICLE SCREW SYSTEM
K083077 · MNH
Otis Biotech Co., Ltd.
Orthopedic · 375d
Cleared Oct 26, 2009
KNEEKG
K091000 · LXJ
Emovi
Physical Medicine · 201d
Cleared Oct 26, 2009
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL...
K091413 · CHH
Alfa Wassermann, Inc.
Chemistry · 166d
Cleared Oct 26, 2009
SAVI WIRELESS, MODEL PM500
K091696 · DRG
Medicomp, Inc.
Cardiovascular · 138d
Cleared Oct 26, 2009
INSTRUMED VASCULAR CLAMPS
K092544 · DXC
Instrumed International, Inc.
Cardiovascular · 68d
Cleared Oct 26, 2009
TSRH SPINAL SYSTEM
K093058 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Oct 23, 2009
ORTHOCAD IQ
K082207 · DYW
Cadent, Inc.
Dental · 444d
Cleared Oct 23, 2009
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700,...
K090542 · IMI
Sun-Rain System Corp.
Physical Medicine · 235d
Cleared Oct 23, 2009
CURIOS
K090641 · MQV
Progentix Orthobiology BV
Orthopedic · 227d
Cleared Oct 23, 2009
COMET ANTERIOR CERVICAL PLATE SYSTEM
K090751 · KWQ
Apollo Spine, Inc.
Orthopedic · 217d
Cleared Oct 23, 2009
TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
K090897 · LPH
Howmedica Osteonics Corp.
Orthopedic · 205d
Cleared Oct 23, 2009
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K091100 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 190d
Cleared Oct 23, 2009
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
K091102 · CGA
Arkray Factory USA, Inc.
Chemistry · 190d
Cleared Oct 23, 2009
GAS TRANSFILL
K091191 · CAW
Respironics Inc., Sleep & Home...
Anesthesiology · 183d
Cleared Oct 23, 2009
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K091240 · HOZ
Alphamed, Inc.
Ophthalmic · 179d
Cleared Oct 23, 2009
CLEARPATH
K091305 · FDF
Easyglide , Ltd.
Gastroenterology & Urology · 172d
Cleared Oct 23, 2009
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606 · NDN
Stryker Corp.
Orthopedic · 142d
Cleared Oct 23, 2009
DK50 DS
K091871 · BTI
Ekom S.R.O.
Anesthesiology · 122d
Cleared Oct 23, 2009
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K091935 · HKI
Tearscience, Inc.
Ophthalmic · 115d
Cleared Oct 23, 2009
ENTRACARE GASTROSTOMY FEEDING TUBE
K092418 · KNT
Entracare, LLC
Gastroenterology & Urology · 78d
Cleared Oct 23, 2009
INTERFACE ACETABULAR CUP LINERS
K092443 · LPH
Omni Life Science, Inc.
Orthopedic · 74d