FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
31441–31464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2016
Smartdop XT6
K153762 · JOP
Koven Technology, Inc.
Cardiovascular · 147d
Cleared May 25, 2016
Penumbra System, Penumbra Pump MAX
K160449 · NRY
Penumbra, Inc.
Neurology · 97d
Cleared May 25, 2016
Creatine Kinase
K160570 · JHS
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared May 24, 2016
Hypocore
K153162 · NCX
Novocor Medical Systems, Inc.
Neurology · 204d
Cleared May 24, 2016
Haemonetics Cell Saver Elite Autotransfusion System
K160197 · CAC
Haemonetics Corporation
Anesthesiology · 118d
Cleared May 24, 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · QEW
Penumbra, Inc.
Cardiovascular · 96d
Cleared May 24, 2016
CROSSER CTO Recanalization Catheter
K161208 · PDU
Bard Peripheral Vacular, Inc.
Cardiovascular · 26d
Cleared May 23, 2016
PINPOINT Endoscopic Fluorescence Imaging System
K150956 · GCJ
Novadaq Technologies, Inc.
General & Plastic Surgery · 410d
Cleared May 23, 2016
Agem Ag Mesh Dressing with Silver
K152544 · FRO
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
General & Plastic Surgery · 262d
Cleared May 23, 2016
INCLUSIVE TAPERED IMPLANT SYSTEM
K153099 · DZE
Prismatik Dentalcraft, Inc.
Dental · 210d
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