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

Filters: Cleared only ×
176,076 results
53665–53688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2009
GLUCODR AUTO SYSTEM
K083628 · NBW
All Medicus Co., Ltd.
Chemistry · 144d
Cleared May 01, 2009
HS II SHORT FIXTURE SYSTEM
K083633 · DZE
Osstem Implant Co., Ltd.
Dental · 144d
Cleared May 01, 2009
FLOWPICC CATHETER
K083920 · LJS
Vasonova, Inc.
General Hospital · 121d
Cleared May 01, 2009
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
K090079 · EIA
Progeny, Inc.
Dental · 109d
Cleared May 01, 2009
METATARSAL DECOMPRESSION IMPLANT, MODEL 100
K090127 · KWD
Solana Surgical, LLC
Orthopedic · 100d
Cleared May 01, 2009
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K090261 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 87d
Cleared May 01, 2009
RESTEP DVY SYSTEM, MODEL RSP-101
K090308 · JOW
Stortford Medical, LLC
Cardiovascular · 84d
Cleared May 01, 2009
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION...
K090371 · KCT
STERIS Corporation
General Hospital · 77d
Cleared May 01, 2009
AVANTE LEUCITE BLOCKS
K090684 · EIH
Somerset Dental Products, Inc.
Dental · 46d
Cleared May 01, 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS...
K090849 · DQY
Ev3, Inc.
Cardiovascular · 32d
Cleared May 01, 2009
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND...
K090870 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 32d
Cleared May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973 · FOZ
Terumo Corp.
General Hospital · 25d
Cleared May 01, 2009
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
K091107 · GEI
Hemostatix Medical Technologies, LLC
General & Plastic Surgery · 15d
Cleared May 01, 2009
TXRX 1.5T CP HEAD COIL
K091114 · MOS
Quality Electrodynamics
Radiology · 14d
Cleared May 01, 2009
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K091146 · MUJ
Accuray, Inc.
Radiology · 11d
Cleared Apr 30, 2009
SYNTHES 90 DEGREE SCREWDRIVER
K082649 · DZI
Synthes (Usa)
Dental · 230d
Cleared Apr 30, 2009
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
K090059 · IYO
Saset (Chengdu), Inc.
Radiology · 111d
Cleared Apr 30, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
K090171 · OAS
E-Woo Technology
Radiology · 97d
Cleared Apr 30, 2009
MODIFICATION TO AUTOFUSER
K090300 · MEB
Ace Medical Us, LLC
General Hospital · 83d
Cleared Apr 30, 2009
XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
K090303 · HRX
Corespine Technologies, LLC
Orthopedic · 83d
Cleared Apr 30, 2009
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
K090556 · MHX
Spacelabs Healthcare Medical...
Cardiovascular · 59d
Cleared Apr 30, 2009
GE DATEX-OHMEDA S/5 ADU CARESTATION
K090892 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared CT Apr 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K090963 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d
Cleared Apr 29, 2009
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000)...
K082363 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 254d