FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72409–72432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2003
GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL
K030414 · ELW
Sultan Chemists, Inc.
Dental · 61d
Cleared Apr 09, 2003
MIRAGE ACTIVA MASK
K030798 · BZD
Resmed, Ltd.
Anesthesiology · 27d
Cleared Apr 09, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
K030801 · JJY
Bayer Healthcare, LLC
Chemistry · 27d
Cleared Apr 09, 2003
ALGO 3I NEWBORN HEARING SCREENER
K030823 · GWJ
Natus Medical, Inc.
Neurology · 26d
Cleared Apr 09, 2003
WBR, MODEL HR
K030870 · KPS
U.C.G. Technologies , Ltd.
Radiology · 21d
Cleared Apr 09, 2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K030905 · DYB
Medamicus, Inc.
Cardiovascular · 16d
Cleared Apr 09, 2003
NOMAD ND1000M AUGMENTED VISION SYSTEM
K030940 · GCJ
Microvision Incorporated
General & Plastic Surgery · 15d
Cleared Apr 09, 2003
EPTFE VASCULAR PROSTHESIS
K030999 · DSY
Vascutek, Ltd.
Cardiovascular · 9d
Cleared Apr 08, 2003
STEREOTAXIS CATHETER ADVANCER SYSTEM
K021802 · DQY
Stereotaxis, Inc.
Cardiovascular · 309d
Cleared Apr 08, 2003
MAS WITH OR WITHOUT SYRINGE
K021876 · HHK
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 305d
Cleared Apr 08, 2003
PETIT SOPHIA
K021978 · LHD
Nishitomo Co., Inc.
Obstetrics & Gynecology · 295d
Cleared Apr 08, 2003
INVIGRA
K022614 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 245d
Cleared Apr 08, 2003
TETRIS SPINAL IMPLANT
K022793 · MQP
Signus Medical, LLC
Orthopedic · 228d
Cleared Apr 08, 2003
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
K023001 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 211d
Cleared Apr 08, 2003
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
K030069 · JEY
Synthes (Usa)
Dental · 90d
Cleared Apr 08, 2003
EMPI ACTION PATCH IONTOPHORESIS SYSTEM
K030395 · EGJ
Empi
Physical Medicine · 62d
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