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
81529–81552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K001214 · LPN
Alcon Universal, Ltd.
Ophthalmic · 87d
Cleared Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
K001356 · DJC
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · GAW
Ethicon, Inc.
General & Plastic Surgery · 54d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812 · KGI
Lunar Corp.
Radiology · 25d
Cleared Jul 10, 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Jul 10, 2000
INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
K994409 · DPK
Alfa Scientific Designs, Inc.
Toxicology · 195d
Cleared Jul 07, 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · DTK
Cordis Corp.
Cardiovascular · 179d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7,...
K001063 · DYG
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared Jul 07, 2000
PANORET, MODEL 1000A
K001111 · HKL
Cmt Medical Technologies, Ltd.
Ophthalmic · 92d
Cleared Jul 07, 2000
RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
K001143 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 88d
Cleared Jul 07, 2000
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD...
K001156 · KDI
Gambro Renal Products
Gastroenterology & Urology · 88d
Cleared Jul 07, 2000
ULTRA V THERAPEUTIC ULTRASOUND
K001166 · IMG
Excel Tech. , Ltd.
Physical Medicine · 88d
Cleared Jul 07, 2000
OPI BAND
K001167 · MVA
Orthomerica Products, Inc.
Neurology · 88d
Cleared Jul 07, 2000
EXTERNAL FIXATION ANCHOR PIN
K001228 · JDW
Immedica, Inc.
Orthopedic · 81d
Cleared Jul 07, 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · DQX
Nipro Medical Corp.
Cardiovascular · 79d
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
CARDEON ASCENDING BALLOON CANNULA (ABC)
K001371 · DWF
Cardeon Corp.
Cardiovascular · 67d
Cleared Jul 07, 2000
MODIFICATION TO PROMPT L-POP
K001494 · KLE
Espe Dental AG
Dental · 56d
Cleared Jul 07, 2000
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD
Diamedix Corp.
Microbiology · 32d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 07, 2000
THE V-BAG
K001822 · DTN
Circulatory Technology, Inc.
Cardiovascular · 21d
Cleared Jul 07, 2000
IM-9C MICROINJECTORS
K001910 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
IM-9A MICROINJECTORS
K001911 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 2000
IM-9B MICROINJECTORS
K001912 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 14d