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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
127537–127560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1990
PATIENT EXAMINATION GLOVES
K897066 · LYY
Golden Gloves Intl.
General Hospital · 32d
Cleared Jan 22, 1990
VENTRESIGN STREP A TEST
K897083 · GTZ
Ventrex Laboratories, Inc.
Microbiology · 33d
Cleared Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
K900028 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Jan 22, 1990
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167 · DCF
Behring Diagnostics, Inc.
Immunology · 10d
Cleared Jan 20, 1990
EXERCISE EVALUATION SYSTEM 2010
K896345 · BZM
Medical Graphics Corp.
Anesthesiology · 78d
Cleared Jan 19, 1990
ESI MODEL MS-103
K885120 · GZT
Electrical Systems Div.
Neurology · 403d
Cleared Jan 19, 1990
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · KQX
Orthopedic Systems, Inc.
Neurology · 210d
Cleared Jan 19, 1990
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
K894600 · LFL
Valleylab, Inc.
General & Plastic Surgery · 183d
Cleared Jan 19, 1990
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
K894631 · DPW
Nihon Kohden America, Inc.
Cardiovascular · 179d
Cleared Jan 19, 1990
BALLOON DILATATION CATHETER
K894944 · LIT
Peripheral Systems Group
Cardiovascular · 169d
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