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
36001–36024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2015
NANOFUSE DBM
K142104 · MQV
Nanotherapeutics, Inc.
Orthopedic · 173d
Cleared Jan 21, 2015
ECHO TRUE 3D VIEWER
K142107 · LLZ
Echopixel, Inc.
Radiology · 173d
Cleared Jan 21, 2015
Everest Spinal System
K142360 · NKB
K2m, Inc.
Orthopedic · 149d
Cleared Jan 21, 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
K142572 · NHA
Zimmer Dental, Inc.
Dental · 131d
Cleared Jan 21, 2015
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored...
K142678 · MAH
Oticon Medical AB
Ear, Nose, Throat · 124d
Cleared Jan 21, 2015
Spectra Soft Tissue Biopsy Needles
K142791 · KNW
Spectra Medical Devices
General & Plastic Surgery · 117d
Cleared Jan 21, 2015
Lumenis M22 System
K142860 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 112d
Cleared Jan 21, 2015
Myoscience iovera system
K142866 · GXH
Myoscience, Inc.
Neurology · 112d
Cleared Jan 21, 2015
NuVasive ALIF Buttress Plate System
K143065 · KWQ
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Jan 21, 2015
Percuvance(R) Percutaneous Surgical System
K143299 · GCJ
Teleflexmedical, Inc.
General & Plastic Surgery · 65d
Cleared Jan 21, 2015
ADVANCE Porous Coated Spiked Tibial Base
K143366 · MBH
Microport Orthopedics, Inc.
Orthopedic · 58d
Cleared Jan 20, 2015
OPTIMUS CMF SYSTEM
K140037 · JEY
Osteonic Co., Ltd.
Dental · 378d
Cleared Jan 20, 2015
STERISAFE HP TABLE-TOP STEAM STERILIZER
K140736 · FLE
Milton E Pedrazzi D.D.S., Inc.
General Hospital · 302d
Cleared Jan 20, 2015
PATIENT SPECIFIC DISTAL FEMORAL
K140898 · KRO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 287d
Cleared Jan 20, 2015
STERILUCENT STERILIZATION CONTAINER SYSTEM
K142109 · KCT
Sterilucent, Inc.
General Hospital · 169d
Cleared Jan 20, 2015
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K142155 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 167d
Cleared Jan 20, 2015
Zmachine
K142825 · OLZ
Consolidated Research of Richmond, Inc.
Neurology · 112d
Cleared Jan 20, 2015
Synapse Occipital-Cervical-Thoracic (OCT) System
K142838 · NKG
Synthes USA Products, LLC
Orthopedic · 112d
Cleared Jan 20, 2015
SnapShot Fixation System
K143037 · JDR
Biomet Manufacturing Corp
Orthopedic · 90d
Cleared Jan 20, 2015
Speedicath Compact Male
K143182 · GBM
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Jan 20, 2015
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
K143317 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 62d
Cleared Jan 20, 2015
LifeGlobal Global HP
K143498 · MQL
Life Global Group, LLC
Obstetrics & Gynecology · 41d
Cleared Jan 20, 2015
MUSE System
K143634 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 29d
Cleared Jan 18, 2015
DECISIO HEALTH PATIENT DASHBOARD
K142106 · MWI
Decisio Health, Inc.
Cardiovascular · 170d