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
71089–71112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2003
SWISS MASTER LIGHT
K032099 · EBZ
(Ems Sa) Electro Medical Systems
Dental · 111d
Cleared Oct 27, 2003
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
K032403 · NPF
Respironics, Inc.
Anesthesiology · 84d
Cleared Oct 27, 2003
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K033108 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 27d
Cleared Oct 27, 2003
CENTRA VIEW DEVICE LINK SYSTEM
K033283 · MWI
Icu Datasystems, Inc.
Cardiovascular · 13d
Cleared Oct 24, 2003
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
K031503 · FLL
Avita Corporation
General Hospital · 164d
Cleared Oct 24, 2003
SAFESKIN* BLUE ZONE POWDER-FREE VINYL EXAM GLOVE
K031750 · LYZ
Kimberly-Clark Corp.
General Hospital · 141d
Cleared Oct 24, 2003
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT)
K031928 · FLL
Braun GmbH
General Hospital · 123d
Cleared Oct 24, 2003
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · ETN
Nuvasive, Inc.
Ear, Nose, Throat · 109d
Cleared Oct 24, 2003
ADEPT 1064/532/755 LASER
K032218 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
ADEPT 1064/532 LASER
K032220 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
ADEPT 1064/755 LASER
K032221 · GEX
Adept Medical Concepts
General & Plastic Surgery · 95d
Cleared Oct 24, 2003
CAP BONE SUBSTITUTE MATERIAL
K032307 · GXP
Etex Corp.
Neurology · 91d
Cleared Oct 24, 2003
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
K032348 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 86d
Cleared Oct 24, 2003
QUANTEX D-DIMER
K032419 · DAP
Instrumentation Laboratory CO
Hematology · 80d
Cleared Oct 24, 2003
NASAL JACKS MASK
K032433 · BZD
Resmed, Ltd.
Anesthesiology · 79d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · GKR
Stanbio Laboratory
Hematology · 73d
Cleared Oct 24, 2003
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
K032703 · GEX
Innovatech Surgical, Inc.
General & Plastic Surgery · 52d
Cleared Oct 24, 2003
INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
K032704 · GEX
Innovatech Surgical, Inc.
General & Plastic Surgery · 52d
Cleared Oct 24, 2003
MODIFICATION TO SUTURE CLINCH
K033024 · FZP
Applied Medical Resources Corp.
General & Plastic Surgery · 28d
Cleared Oct 24, 2003
CZR PRESS
K033049 · EIH
Noritake Co., Inc.
Dental · 25d
Cleared Oct 24, 2003
DIGITAL TEMPERATURE MONITOR, MODEL GT-202, GT-203, GT-204, AND GT-205
K033069 · FLL
Tenghi Co., Ltd.
General Hospital · 25d
Cleared Oct 24, 2003
SPR SYSTEM
K033181 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 23d
Cleared Oct 23, 2003
FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1
K023723 · DXN
Fms, Finapres Medical Systems BV
Cardiovascular · 352d
Cleared Oct 23, 2003
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
K030421 · NCX
Alsius Corp.
Neurology · 255d