FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128137–128160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1990
GUIDING CATHETER
K895146 · DQO
Peripheral Systems Group
Cardiovascular · 150d
Cleared Jan 19, 1990
REBOX II (TENS)
K895183 · GZJ
Rebox (Uk) , Ltd.
Neurology · 161d
Cleared Jan 19, 1990
MEC-I-TRON MINI, MODEL M-2
K895289 · GZJ
Meyer Equipment Company, Inc.
Neurology · 147d
Cleared Jan 19, 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · DXT
Bd Becton Dickinson Vacutainer...
Cardiovascular · 143d
Cleared Jan 19, 1990
MEDISEAL SUCTION CANISTER
K895427 · DWD
Deroyal Industries, Inc.
Cardiovascular · 136d
Cleared Jan 19, 1990
OPTION EPIDURAL CATHETERS
K895476 · CAZ
Opticon Medical, Inc.
Anesthesiology · 130d
Cleared Jan 19, 1990
HERMAL WOUND CARE KIT
K895817 · NAD
Stiefel Research Institute, Inc.
General & Plastic Surgery · 112d
Cleared Jan 19, 1990
CLP NORMAL LIPID CONTROL
K895862 · JJY
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Jan 19, 1990
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER
K896002 · DXH
Instromedix, Inc.
Cardiovascular · 98d
Cleared Jan 19, 1990
AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED
K896122 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 87d
Cleared Jan 19, 1990
ANEST-EZE DENTAL DRILL RA#2
K896149 · DZA
Signature One Products, Inc.
Dental · 88d
Cleared Jan 19, 1990
MODIFIED DR-2C/PMC 100
K896153 · DSH
General Devices
Cardiovascular · 87d
Cleared Jan 19, 1990
ABBOTT IMX PROLACTIN
K896162 · CFT
Abbott Laboratories
Chemistry · 87d
Cleared Jan 19, 1990
LEINBACH HIP PROSTHESIS
K896257 · KWY
3M Company
Orthopedic · 81d
Cleared Jan 19, 1990
INSULATION PAD
K896307 · DWS
Bio-Vascular, Inc.
Cardiovascular · 80d
Cleared Jan 19, 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · DXT
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Jan 19, 1990
WOUND DRESSING
K896702 · FRO
Viaderm Pharmaceuticals, Inc.
General & Plastic Surgery · 52d
Cleared Jan 19, 1990
DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF
K896788 · DXQ
Advanced Medical Instruments, Inc.
Cardiovascular · 46d
Cleared Jan 19, 1990
IGF-I BY EXTRACTION
K896808 · CFL
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Jan 19, 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · KRA
Baxter Healthcare Corp
Cardiovascular · 46d
Cleared Jan 19, 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
K896916 · CEK
Heraeus Kulzer, Inc.
Chemistry · 39d
Cleared Jan 19, 1990
MILENIA (TM) TSH
K900014 · JLW
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jan 18, 1990
FIVE-YEAR STERILE PACKAGING SHELF LIFE
K892528 · DTB
Daig Corp.
Cardiovascular · 282d
Cleared Jan 18, 1990
POLYSTAN HEATER-COOLER UNIT
K893940 · DWC
Polystan C/O Vitalcor, Inc.
Cardiovascular · 232d