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
149641–149664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1985
COMPUTER
K844665 · DXG
Burdick Corp.
Cardiovascular · 75d
Cleared Feb 13, 1985
LIFESOUND - ELECTRONIC STETHOSCOPE
K844804 · DQD
Biomedical Concepts, Inc.
Cardiovascular · 64d
Cleared Feb 12, 1985
INTERMED, INS STERILE WATER/SALINE
K842166 · BSY
Intermed, Inc.
Anesthesiology · 257d
Cleared Feb 12, 1985
GLUCOCHEK III
K842474 · JJQ
Larken Industries, Inc.
Chemistry · 232d
Cleared Feb 12, 1985
LORD SCREW RING ACETABULAR COMPONENT
K844028 · JDI
Howmedica Corp.
Orthopedic · 120d
Cleared Feb 12, 1985
ENZYGNOST LIPASE TEST
K844240 · CET
Behring Diagnostics, Inc.
Chemistry · 103d
Cleared Feb 12, 1985
MOBILIZATION & TRACTION TABLE
K844359 · ING
Chattanooga Group, Inc.
Physical Medicine · 91d
Cleared Feb 12, 1985
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · BTR
Sherwood Medical Co.
Anesthesiology · 81d
Cleared Feb 12, 1985
OHMEDA DOUBLE SWIVEL ADAPTER
K844656 · BZA
Ohmeda Medical
Anesthesiology · 75d
Cleared Feb 12, 1985
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
K844740 · LDD
Hewlett-Packard Co.
Cardiovascular · 69d
Cleared Feb 12, 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · JHJ
Abbott Laboratories
Chemistry · 56d
Cleared Feb 12, 1985
SIREDOC, PAPER CHART RECORDER
K850146 · DSF
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Feb 12, 1985
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
K850319 · JQB
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Feb 11, 1985
PROBEYE THERMAL VIDEO SYSTEMS
K843549 · LHQ
Hughes Aircraft Co.
Radiology · 154d
Cleared Feb 08, 1985
IABP #90 SYSTEM
K831235 · DSP
Datascope Corp.
Cardiovascular · 665d
Cleared Feb 08, 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · DSP
Datascope Corp.
Cardiovascular · 464d
Cleared Feb 08, 1985
BIOPATCH BOVINE PERICARDIAL PATCH
K840756 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 351d
Cleared Feb 08, 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716 · DXH
Medical Data Electronics
Cardiovascular · 210d
Cleared Feb 08, 1985
HMB ALLERGOGEN SKIN PRICK TEST NEEDLE
K844221 · SCL
Aller/Guard, Inc.
General Hospital · 99d
Cleared Feb 08, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-540
K844284 · DXN
Takeda Medical, Inc.
Cardiovascular · 95d
Cleared Feb 08, 1985
BRAUN DENTAL CENTER OC-3
K844339 · EFS
The Braun Corp.
Dental · 92d
Cleared Feb 08, 1985
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE
K844471 · EBH
Dentsply Intl.
Dental · 81d
Cleared Feb 08, 1985
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
K844793 · DXY
Intermedics, Inc.
Cardiovascular · 60d
Cleared Feb 08, 1985
CENTURY SAF-LIFT SCALE
K844871 · FNG
Century Manufacturing Co.
General Hospital · 53d