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
52081–52104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2009
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
K091787 · DQA
Ivy Biomedical Systems, Inc.
Anesthesiology · 114d
Cleared Oct 09, 2009
SMARTTRACK SYSTEM
K091803 · CAF
Nexus6, Ltd.
Anesthesiology · 115d
Cleared Oct 09, 2009
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT
K092049 · KNT
Sainath Intellectual Properties, LLC
Gastroenterology & Urology · 94d
Cleared Oct 09, 2009
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
K092103 · EHD
VATECH Co., Ltd.
Radiology · 87d
Cleared Oct 09, 2009
RADIANALYZER XPRESS
K092105 · DQK
Radi Medical Systems AB
Cardiovascular · 87d
Cleared Oct 09, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K092109 · LYZ
Zhangjiangang All Fine Rubber-Plastic...
General Hospital · 87d
Cleared Oct 09, 2009
VOYAGER COMPACT IMAGING SYSTEM
K092182 · IYO
Ardent Sound, Inc.
Radiology · 80d
Cleared Oct 09, 2009
BUSSE SURGICAL DRAPES III
K092212 · KKX
Busse Hospital Disposables, Inc.
General Hospital · 79d
Cleared Oct 09, 2009
AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR
K092225 · ITI
Amylior, Inc.
Physical Medicine · 78d
Cleared Oct 09, 2009
ELETONE CREAM
K092297 · FRO
Ferndale Pharma Group, Inc.
General & Plastic Surgery · 72d
Cleared Oct 09, 2009
AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
K092432 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 63d
Cleared Oct 09, 2009
RAINBOW BLOCK
K092513 · EIH
Genoss Co., Ltd.
Dental · 53d
Cleared Oct 09, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
K092566 · OCC
Nanosphere, Inc.
Microbiology · 50d
Cleared Oct 09, 2009
HEARTWAY POWER MOBILITY SCOOTER, S12
K092650 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 43d
Cleared Oct 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 31d
Cleared Oct 09, 2009
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
K092757 · MSV
Thera-Test Laboratories, Inc.
Immunology · 30d
Cleared Oct 09, 2009
SIMPLYGO HANDS FREE BREAST PUMP
K092770 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 30d
Cleared Oct 09, 2009
AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
K092806 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 28d
Cleared Oct 09, 2009
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · DQK
St Jude Medical
Cardiovascular · 28d
Cleared Oct 09, 2009
PATLOG 2.0
K092939 · IYE
Oncolog Medical QA AB
Radiology · 15d
Cleared Oct 09, 2009
APLIO MX SSA-780A, VERSION 1.0
K092948 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 09, 2009
CAROTID COIL 5000004901
K092962 · MOS
Shanghai Chenguang Medical...
Radiology · 14d
Cleared Oct 08, 2009
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
K090051 · KFM
Levitronix, LLC
Cardiovascular · 274d
Cleared Oct 08, 2009
REMOTE INFRARED THERMOMETER, MODEL RC002
K090361 · FLL
Rycom Electron Technology Limited
General Hospital · 238d