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
72889–72912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2003
IMPACT SUTURE ANCHOR. MODEL 433510
K030388 · HWC
Bionx Implants, Ltd.
Orthopedic · 78d
Cleared Apr 24, 2003
C. DIFFICILE TOX A/B II
K030404 · LLH
Techlab, Inc.
Microbiology · 77d
Cleared Apr 24, 2003
A127 LEAD EXTENSION
K030461 · GZB
Advanced Neuromodulation Systems
Neurology · 71d
Cleared Apr 24, 2003
HL888JF
K030541 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Apr 24, 2003
RADII
K030568 · EBZ
Southern Dental Industries, Inc.
Dental · 59d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · KWQ
Blackstone Medical, Inc.
Orthopedic · 58d
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 24, 2003
SAFFRON NM GUIDING CATHETER
K030715 · DQY
Neich Medical (Shenzhen) Company Limited
Cardiovascular · 48d
Cleared Apr 24, 2003
Z-BOX
K030764 · HAW
Z-Kat, Inc.
Neurology · 44d
Cleared Apr 24, 2003
5F MEDTRONIC LAUNCHER GUIDE CATHETER
K030779 · DQY
Medtronic Vascular
Cardiovascular · 44d
Cleared Apr 24, 2003
VERITAS COLLAGEN MATRIX
K030879 · OXE
Synovis Surgical Innovations
General & Plastic Surgery · 35d
Cleared Apr 24, 2003
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · LWJ
Plus Orthopedics
Orthopedic · 27d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14,...
K030984 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 27d
Cleared Apr 24, 2003
EDWARDS INTRODUCER SHEATH
K031087 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 17d
Cleared Apr 24, 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · KWP
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Apr 23, 2003
PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD...
K023256 · NBW
Abbott Laboratories
Chemistry · 205d
Cleared Apr 23, 2003
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
K023454 · CCK
Datex-Ohmeda
Anesthesiology · 190d
Cleared Apr 23, 2003
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000
K024342 · IXW
Daito Co., Ltd.
Radiology · 117d
Cleared Apr 23, 2003
F1 DIODE LASER SYSTEM
K030235 · GEX
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Apr 23, 2003
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
K030243 · DZE
Imtec Corp.
Dental · 90d
Cleared Apr 23, 2003
AXCEL SURGICAL LIGHT
K030906 · FSY
Alm
General & Plastic Surgery · 30d
Cleared Apr 23, 2003
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090,...
K030937 · CAZ
Arrow International, Inc.
Anesthesiology · 29d
Cleared Apr 23, 2003
VTI 20 MHZ GATED DOPPLER
K031091 · DPW
Vascular Technology Incorporated
Cardiovascular · 16d