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
146041–146064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1986
TDXR 5-HIAA (URINE)
K854946 · CDA
Abbott Laboratories
Chemistry · 38d
Cleared Jan 17, 1986
CANTROL CK/MB CONTROL
K855006 · JJT
Canyon Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225 · JJX
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Jan 16, 1986
MYOPACH ULTRASONIC PACHOMETER
K844112 · IYO
Myocure, Inc.
Radiology · 450d
Cleared Jan 16, 1986
CENTRAL VEIN CATHETERIZATION TRAY
K852642 · FDZ
Teleflexmedical, Inc.
Gastroenterology & Urology · 209d
Cleared Jan 16, 1986
HEARING AID ANALYSIS SYSTEM
K853271 · ETW
Robert Bosch Corp.
Ear, Nose, Throat · 164d
Cleared Jan 16, 1986
BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
K853652 · DRR
Fisher Imaging Corp.
Cardiovascular · 135d
Cleared Jan 16, 1986
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · FRN
Medex, Inc.
General Hospital · 126d
Cleared Jan 16, 1986
SONOLINE LX
K853946 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Jan 16, 1986
ANGIOGRAPHY CATHETERS
K854018 · DQO
Micor, Inc.
Cardiovascular · 108d
Cleared Jan 16, 1986
INFANT LIFE SUPPORT MODULE-20
K854065 · FPL
Intl. Biomedics, Inc.
General Hospital · 104d
Cleared Jan 16, 1986
CRAIGWELL AID FITTING SYSTEM AFS
K854125 · EWO
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
CRAIGWELL MASTER HEARING AID MHA
K854126 · KHL
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS
K854247 · HIS
M/S Seohung Industrial Co., Ltd.
Obstetrics & Gynecology · 87d
Cleared Jan 16, 1986
TRANSFER NEEDLE
K854556 · LHI
Soma Intl., Inc.
General Hospital · 63d
Cleared Jan 16, 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · DXY
Telectronics, Inc.
Cardiovascular · 63d
Cleared Jan 16, 1986
SEAMED MODEL 4000
K854648 · DTE
Seamed Corp.
Cardiovascular · 58d
Cleared Jan 16, 1986
DIGITAL FASHION THERMOMETER
K854706 · FLL
Kanada Manufacturing Co., Ltd.
General Hospital · 56d
Cleared Jan 15, 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · DQO
Mallinckrodt Critical Care
Cardiovascular · 169d
Cleared Jan 15, 1986
THE GRIPPER
K853422 · BXN
Regional Master Corp.
Anesthesiology · 154d
Cleared Jan 15, 1986
PINPOINT NEEDLE
K853478 · BSP
Regional Master Corp.
Anesthesiology · 154d
Cleared Jan 15, 1986
DNR UNIPOLAR
K853568 · DTB
Biotronik Sales, Inc.
Cardiovascular · 142d
Cleared Jan 15, 1986
NOVA ARTERIAL EMBOLECTOMY CATHETER
K853625 · DXE
Nova Medical Specialties
Cardiovascular · 139d
Cleared Jan 15, 1986
STYLET INTRODUCER FUNNEL
K854142 · DTB
Telectronics, Inc.
Cardiovascular · 96d