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
25441–25464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2018
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial...
K172554 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 250d
Cleared May 01, 2018
SAPPHIRE, ELEVARE SAPPHIRE
K172555 · OLP
Omm Imports, Inc. D/B/A Zero Gravity
General & Plastic Surgery · 250d
Cleared May 01, 2018
BiliLux
K172656 · LBI
Draeger Medical Systems, Inc.
General Hospital · 238d
Cleared May 01, 2018
PeraServer and PeraTrend
K172959 · MWI
Perahealth, Inc.
Cardiovascular · 217d
Cleared May 01, 2018
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage...
K173035 · FGE
Cook Incorporated
Gastroenterology & Urology · 215d
Cleared May 01, 2018
ViaTherm BOOST
K173300 · IMJ
Viatherm Therapeutics, LLC
Physical Medicine · 196d
Cleared May 01, 2018
Liberty Cycler Set
K173718 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 147d
Cleared May 01, 2018
AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
K180848 · GEI
ArthroCare Corporation
General & Plastic Surgery · 29d
Cleared Apr 30, 2018
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg,...
K171678 · CCK
Vyaire Medical, Inc.
Anesthesiology · 328d
Cleared Apr 30, 2018
VitaMESH Macroporous PP Surgical Mesh
K172636 · FTL
Proxy Biomedical , Ltd.
General & Plastic Surgery · 241d
Cleared Apr 30, 2018
EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy...
K172726 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 231d
Cleared Apr 30, 2018
Finessis Intense Polyisoprene Surgical Glove
K173304 · KGO
Lucenxia Prescience AG
General Hospital · 194d
Cleared Apr 30, 2018
Mazor X
K180307 · OLO
Mazor Robotics , Ltd.
Orthopedic · 87d
Cleared Apr 30, 2018
ExactVu High Resolution Micro-Ultrasound System
K180636 · IYO
Exact Imaging, Inc.
Radiology · 49d
Cleared Apr 30, 2018
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with...
K180696 · LZA
Medline Industries, Inc.
General Hospital · 45d
Cleared Apr 27, 2018
ACRON™ TLIF System
K171151 · MAX
Spinemed Ges.M.B.H
Orthopedic · 372d
Cleared Apr 27, 2018
OLYMPIC Navigated Instruments
K172166 · OLO
Astura Medical
Orthopedic · 283d
Cleared Apr 27, 2018
Novasight Hybrid System
K172258 · OBJ
Conavi Medical, Inc.
Cardiovascular · 275d
Cleared Apr 27, 2018
ADHEAR System
K172460 · LXB
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 256d
Cleared Apr 27, 2018
TRACOE silcosoft Tracheostomy Tube
K172720 · JOH
Tracoe Medical GmbH
Anesthesiology · 231d
Cleared Apr 27, 2018
HYALURONIC ACID TOPICAL WOUND CREAM
K172747 · FRO
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 227d
Cleared Apr 27, 2018
Keymill
K172764 · EBI
Mycone Dental Supply Company, Inc....
Dental · 226d
Cleared Apr 27, 2018
NeuroCap
K172866 · GXY
Memory MD, Inc.
Neurology · 219d
Cleared Apr 27, 2018
hipEOS
K173390 · LLZ
Onefit Medical
Radiology · 179d