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
72433–72456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 04, 2003
FRONTIER MODEL X5
K030783 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 23d
Cleared Apr 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858 · HRS
Synthes (Usa)
Orthopedic · 17d
Cleared Apr 04, 2003
RABBIT MOBILE STANDING FRAME
K030882 · IPL
R82 A/S
Physical Medicine · 15d
Cleared Apr 04, 2003
SWITCHBLADE
K030890 · GEI
Snowden Pencer, Inc.
General & Plastic Surgery · 14d
Cleared Apr 03, 2003
FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
K022112 · KNT
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 279d
Cleared Apr 03, 2003
GALEMED PEAK FLOW METER, MODELS 3751/3752
K022124 · BZH
Galemed Corp.
Anesthesiology · 276d
Cleared Apr 03, 2003
STERRAD 50 & STERRAD 100S STERILIZERS
K023290 · FLF
Advanced Sterilization Products
General Hospital · 183d
Cleared Apr 03, 2003
FIBERFILL AGP
K023818 · KIF
Pentron Clinical Technologies
Dental · 139d