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
51361–51384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2010
RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL...
K093658 · JOW
Renu Medical, Inc.
Cardiovascular · 50d
Cleared Jan 14, 2010
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER...
K093659 · DTK
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Jan 14, 2010
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
K093730 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 42d
Cleared Jan 13, 2010
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
K092118 · DQO
Oscor, Inc.
Cardiovascular · 183d
Cleared Jan 13, 2010
SOPROLIFE
K092583 · NBL
Sopro
Dental · 145d
Cleared CT Jan 13, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921,...
K092811 · DXN
Andon Health Co, Ltd.
Cardiovascular · 121d
Cleared Jan 13, 2010
ASTHMA MONITOR AM3
K092890 · BZG
Carefusion Germany 234 GmbH
Anesthesiology · 114d
Cleared Jan 13, 2010
VITAL SLEEP
K092942 · LRK
The Snore Reliever Company, LLC
Dental · 111d
Cleared Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825 · IKT
Ambu A/S
Neurology · 30d
Cleared Jan 13, 2010
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
K093832 · DWA
Levitronix, LLC
Cardiovascular · 30d
Cleared Jan 13, 2010
EVALVE STEERABLE GUIDE CATHETER
K093866 · DRA
Evalve, Inc.
Cardiovascular · 27d
Cleared Jan 12, 2010
MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001...
K092739 · ODF
C-Link Micro Imaging, Inc.
Gastroenterology & Urology · 126d
Cleared Jan 12, 2010
AESPIRE 7900, AESPIRE VIEW
K092864 · BSZ
Datex-Ohmeda Inc., A Division of...
Anesthesiology · 117d
Cleared Jan 12, 2010
LUMOS, MODEL R 72B
K093596 · KPW
Lumos, Inc.
Radiology · 53d
Cleared Jan 12, 2010
LIFENET SYSTEM
K093925 · MSX
Physio-Control, Inc.
Cardiovascular · 21d
Cleared Jan 11, 2010
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
K092479 · IYE
Dyn'R
Radiology · 151d
Cleared Jan 11, 2010
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
K092909 · HWC
Synthes (Usa)
Orthopedic · 111d
Cleared Jan 11, 2010
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES...
K093360 · JWH
Exactech, Inc.
Orthopedic · 75d
Cleared Jan 11, 2010
EXPLORER 4D TREATMENT PLANNING SYSTEM
K093588 · MUJ
American Radiosurgery, Inc.
Radiology · 53d
Cleared Jan 08, 2010
DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
K082097 · NEW
Demetech Corp.
General & Plastic Surgery · 533d
Cleared CT Jan 08, 2010
MATRIX RF APPLICATOR
K090025 · GEI
Syneron Medical, Ltd.
General & Plastic Surgery · 368d
Cleared Jan 08, 2010
ORTHOSS
K090401 · MQV
Ed. Geistlich Soehne AG Fur Chemische...
Orthopedic · 325d
Cleared Jan 08, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · OAS
VATECH Co., Ltd.
Radiology · 319d
Cleared Jan 08, 2010
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820,...
K091506 · MSD
R4 Vascular, Inc.
Gastroenterology & Urology · 232d