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

Filters: Cleared only ×
175,820 results
32041–32064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · JXM
Healgen Scientific, LLC
Toxicology · 159d
Cleared May 23, 2016
ARTOURA Breast Tissue Expanders with Smooth Surface
K161176 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 27d
Cleared May 20, 2016
Kudu
K151492 · IOR
R82 A/S
Physical Medicine · 352d
Cleared May 20, 2016
IPS Style Ceram, IPS Style Ceram One, IPS Style Press
K152103 · EIH
Ivoclar Vivadent, AG
Dental · 296d
Cleared May 20, 2016
Sunfire 32 Tanning Bed
K152423 · LEJ
Sunfire Industries, Inc.
General & Plastic Surgery · 268d
Cleared May 20, 2016
Dr. Wolff Vagisan Moisturising Cream
K152507 · NUC
Dr. August Wolff GmbH & Co. KG...
Obstetrics & Gynecology · 261d
Cleared May 20, 2016
TruAbutment DS
K152559 · NHA
Truabutment
Dental · 254d
Cleared May 20, 2016
everX Posterior
K153127 · EBF
GC America, Inc.
Dental · 204d
Cleared May 20, 2016
Oral-B 5% Sodium Fluoride Varnish
K153334 · LBH
Young Dental Manufacturing Co. 1, LLC
Dental · 183d
Cleared May 20, 2016
BardPort®, SlimPort®, and X-Port® Implanted Ports
K153359 · LJT
C.R. Bard, Inc.
General Hospital · 182d
Cleared May 20, 2016
Microdent Ektos Implant System
K153650 · DZE
Implants Microdent System S.L
Dental · 151d
Cleared May 20, 2016
CUR Model 1
K160052 · NUH
Thimble Bioelectronics, Inc.
Neurology · 130d
Cleared May 20, 2016
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
K160065 · OXO
Gemss Medical Systems Co., Ltd.
Radiology · 128d
Cleared May 20, 2016
Temperature Probe, Affinity Temperature Probe
K160091 · FLL
Medtronic, Inc.
General Hospital · 126d
Cleared May 20, 2016
Trillium Oval V 5.1 MRI System
K160152 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared May 20, 2016
MasterLoc Stem
K160289 · LZO
Medacta International
Orthopedic · 107d
Cleared May 20, 2016
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with...
K160416 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 94d
Cleared May 20, 2016
Reliance Lumbar IBF System
K160463 · MAX
Reliance Medical Systems, LLC
Orthopedic · 91d
Cleared May 20, 2016
Planmeca ProMax 3D Max, Planmeca Maximity
K160506 · OAS
Planmeca Oy
Radiology · 86d
Cleared May 20, 2016
ViZion DR + Wireless
K160810 · MQB
Viztek, LLC
Radiology · 57d
Cleared May 20, 2016
United Urologics Closed System Catheter
K160877 · KOD
Robling Medical, Inc.
Gastroenterology & Urology · 51d
Cleared May 20, 2016
BIB Stent Placement Catheter
K160889 · NVM
NuMED, Inc.
Cardiovascular · 50d
Cleared May 20, 2016
Baha 5 Power Sound Processor
K161123 · LXB
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
K161140 · JIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d