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
71905–71928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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