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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80353–80376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2001
FINGER PULSE METER
K000814 · DQA
Bhs Intl., Inc.
Anesthesiology · 381d
Cleared Mar 29, 2001
MENTOR SELF-CATH CLOSED SYSTEM
K003873 · FCM
Mentor Corp.
Gastroenterology & Urology · 104d
Cleared Mar 29, 2001
CYNOSURE PHOTOGENICA NEO-V
K004039 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Mar 29, 2001
REDTECH GIPC 2000
K004040 · FFX
Red-Tech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 29, 2001
SHEER THIN AROMAS YELLOW LATEX CONDOM
K004051 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 29, 2001
BAYER ADVIA IMS SYSTEM
K010201 · MMI
Bayer Corp.
Chemistry · 66d
Cleared Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · BZD
Respironics, Inc.
Anesthesiology · 59d
Cleared Mar 29, 2001
PRESSURE TRAK, MODEL 222-B
K010622 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 27d
Cleared Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
K010707 · DQO
Boston Scientific, Target
Radiology · 20d
Cleared Mar 29, 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · DXN
A&D Engineering, Inc.
Cardiovascular · 9d
Cleared Mar 28, 2001
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
K002705 · LHI
Baxa Corp.
General Hospital · 210d
Cleared Mar 28, 2001
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
K002901 · MSD
The Kendall Company
Gastroenterology & Urology · 191d
Cleared Mar 28, 2001
NT SWIFT
K004031 · EKS
Dental Power, Inc.
Dental · 90d
Cleared Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000...
K010567 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 28, 2001
ADC QS/IPD WORKSTATION
K010571 · LLZ
Agfa Corp.
Radiology · 30d
Cleared Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
K010588 · MOI
Roche Diagnostics Corp.
Immunology · 29d
Cleared Mar 28, 2001
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
K010616 · FRF
Hmi Industries, Inc.
General Hospital · 27d
Cleared Mar 27, 2001
LOCALISA CARDIAC NAVIGATION SYSTEM
K002869 · DQK
Medtronic Surgical Navigation...
Cardiovascular · 195d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 27, 2001
3M LITTMANN
K003723 · DQD
3M Company
Cardiovascular · 113d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · DSY
Impra, Inc.
Cardiovascular · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS BLUE LATEX CONDOM
K004016 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 27, 2001
F1 DIODE LASER SYSTEM
K004021 · GEX
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2001
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
K004028 · FRO
Maersk Medical, Ltd.
General & Plastic Surgery · 90d