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
76321–76344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · MEH
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared May 13, 2002
EVERSTICK ORTHO
K021126 · EBI
Stick Tech , Ltd.
Dental · 35d
Cleared May 13, 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · JDW
Biomet, Inc.
Orthopedic · 28d
Cleared May 13, 2002
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K021226 · KWQ
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared May 13, 2002
SENSAID, MODELS# RC-NVA30-10
K021246 · DQA
Sensidyne, Inc.
Anesthesiology · 24d
Cleared May 13, 2002
MODIFICATION TO 30 EXTENSION SET
K021395 · FPA
Churchill Medical Systems, Inc.
General Hospital · 11d
Cleared May 13, 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · ELW
Dentsply Intl.
Dental · 10d
Cleared May 10, 2002
AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
K013886 · NCS
Advanced Diagnostics, Inc.
Radiology · 168d
Cleared May 10, 2002
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · LCM
Lin-Zhi International, Inc.
Toxicology · 106d
Cleared May 10, 2002
THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
K020445 · GXY
The Electrode Store, Inc.
Neurology · 88d
Cleared May 10, 2002
CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM
K020449 · LLZ
Cardionow, Inc.
Radiology · 88d
Cleared May 10, 2002
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
K020453 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 88d
Cleared May 10, 2002
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
K020617 · DZE
Nsi
Dental · 74d
Cleared May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
K020692 · LEH
Dade Behring, Inc.
Toxicology · 67d
Cleared May 10, 2002
SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM...
K020719 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 66d
Cleared May 10, 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031...
K020763 · DIO
Lin-Zhi International, Inc.
Toxicology · 64d
Cleared May 10, 2002
FORTAFLEX SURGICAL MESH
K021105 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 35d
Cleared May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
K021163 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 29d
Cleared May 10, 2002
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
K021258 · MCF
Germ Terminator Corporation
Dental · 21d
Cleared May 10, 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · ELW
Dentsply Intl.
Dental · 7d
Cleared May 09, 2002
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
K012132 · NIC
Cantor & Nissel , Ltd.
Ophthalmic · 304d
Cleared May 09, 2002
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
K013053 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 240d
Cleared May 09, 2002
MICROJET CRONO H
K013855 · FRN
Cane S.R.I.
General Hospital · 170d
Cleared May 09, 2002
DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
K020430 · NFK
Diatek, Inc.
Gastroenterology & Urology · 90d