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
73033–73056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2003
REX, VERSION 3.0
K030457 · LLZ
Pointdx, Inc.
Radiology · 56d
Cleared Apr 08, 2003
ENVAN HEART RATE MONITOR
K030656 · DRT
Envan, LLC
Cardiovascular · 36d
Cleared Apr 08, 2003
MICROS 60
K030799 · GKZ
Abx Diagnostics
Hematology · 26d
Cleared Apr 08, 2003
BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K030806 · JEY
Bioplate, Inc.
Dental · 26d
Cleared Apr 08, 2003
ENHANCE HUMAN SERUM ALBUMIN
K030850 · MQL
Conception Technologies
Obstetrics & Gynecology · 22d
Cleared Apr 08, 2003
SYNGO COLONOGRAPHY SOFTWARE PACKAGE
K030982 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Apr 07, 2003
SEED LINK
K023073 · KXK
Implant Sciences Corp.
Radiology · 203d
Cleared Apr 07, 2003
STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM
K023614 · FRG
Case Medical, Inc.
General Hospital · 161d
Cleared Apr 07, 2003
COZART EIA OPIATES ORAL FLUID KIT
K024339 · DIG
Cozart Bioscience , Ltd.
Toxicology · 101d
Cleared Apr 07, 2003
PORTABLE RO+ MODEL MROS09
K030059 · FIP
Ameriwater
Gastroenterology & Urology · 90d
Cleared Apr 07, 2003
PS 3000 DIGATAL PHOTOSPOT SYSTEM
K030061 · OWB
Precise Optics
Radiology · 90d
Cleared Apr 07, 2003
DRIP ALERT
K030136 · FLN
Drip Alert, Inc.
General Hospital · 83d
Cleared Apr 07, 2003
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
K030949 · IYN
Sonosite,Inc.
Radiology · 12d
Cleared Apr 04, 2003
ELFCARE DEVICE, MODELS 314A THROUGH 314G
K023231 · GZJ
Mediseb , Ltd.
Neurology · 189d
Cleared Apr 04, 2003
JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
K024325 · INI
Ji-Ee Industry Co., Ltd.
Physical Medicine · 99d
Cleared Apr 04, 2003
VERSABOARD, MODEL 7040
K030051 · IYE
Bionix Development Corp.
Radiology · 88d
Cleared Apr 04, 2003
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K030092 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 84d
Cleared Apr 04, 2003
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR
K030245 · LZA
Arista Latindo Industrial Ltd. P.T
General Hospital · 70d
Cleared Apr 04, 2003
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
K030459 · FRN
Alaris Medical Systems, Inc.
General Hospital · 52d
Cleared Apr 04, 2003
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K030548 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 43d
Cleared Apr 04, 2003
FLEXIBLE TIP THERMOMETER, MODEL 011206
K030673 · FLL
Global Treasure Industries , Ltd.
General Hospital · 31d
Cleared Apr 04, 2003
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K030697 · GEI
Radionics, Inc.
General & Plastic Surgery · 29d
Cleared Apr 04, 2003
WU'S POWERED WHEELCHAIR, MAMBO 3
K030707 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 29d
Cleared Apr 04, 2003
WU'S POWERED WHEELCHAIR, MAMBO 5
K030709 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 29d