Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
150241–150264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 08, 1985
CENTURY SCALE
K844872 · FNG
Century Manufacturing Co.
General Hospital · 53d
Cleared Feb 08, 1985
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Feb 08, 1985
CARDIOBEEPER PROFILE MONITOR
K844966 · DXH
Survival Technology, Inc.
Cardiovascular · 46d
Cleared Feb 08, 1985
ELECTROCARDIOGRAPH-ECG CALIPER
K850021 · DPS
Devcom, Inc.
Cardiovascular · 36d
Cleared Feb 08, 1985
COLTENE PRECISE
K850036 · ELW
Coltene, Inc.
Dental · 32d
Cleared Feb 08, 1985
CARDIOGUARD STRESS TEST MONITOR 4002
K850043 · DRT
Del Mar Avionics
Cardiovascular · 32d
Cleared Feb 08, 1985
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
K850073 · EBD
Johnson & Johnson Professionals, Inc.
Dental · 30d
Cleared Feb 08, 1985
GDC-1629 A CASTING ALLOY
K850101 · EJS
Deringer-Ney, Inc.
Dental · 28d
Cleared Feb 08, 1985
GDC-1433 A CASTING ALLOY
K850102 · EJS
Deringer-Ney, Inc.
Dental · 28d