FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75193–75216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2002
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021058 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
K021059 · LYY
Syntex Healthcare Products Co., Ltd.
General Hospital · 42d
Cleared May 14, 2002
SL-PLUS LATERALIZED STEM
K021178 · JDI
Plus Orthopedics
Orthopedic · 29d
Cleared May 14, 2002
SIMPLICITY QD EASY P INFUSION SET
K021296 · FPA
Sterling Medivations, Inc.
General Hospital · 20d
Cleared May 14, 2002
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
K021308 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 19d
Cleared May 14, 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · FRN
Abbott Laboratories
General Hospital · 15d
Cleared May 13, 2002
AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
K020579 · GEI
Aaron Medical Industries
General & Plastic Surgery · 81d
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