FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
26041–26064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 27, 2018
HDR MRI Lumen Marker
K180069 · JAQ
C4 Imaging, LLC
Radiology · 108d
Cleared Apr 27, 2018
QiF Blood and Fluid Warmer
K180154 · LGZ
Quality IN Flow , Ltd.
General Hospital · 98d
Cleared Apr 27, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K180669 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 44d
Cleared Apr 26, 2018
Summit Hip System
K170339 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 448d
Cleared Apr 26, 2018
2 Face / Face Evolution
K171821 · NFO
Heat IN A Click
Neurology · 311d
Cleared Apr 26, 2018
P50 Series Dental Operative Unit and Accessories
K171872 · EIA
Pelton & Crane
Dental · 307d
Cleared Apr 26, 2018
INFINITY Total Ankle System
K172633 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 237d
Cleared CT Apr 26, 2018
Astral 100/150
K172875 · CBK
Resmed, Ltd.
Anesthesiology · 217d
Cleared Apr 26, 2018
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile...
K172923 · LZA
Top Glove Sdn. Bhd.
General Hospital · 213d
Cleared Apr 26, 2018
LungVision Tool
K172955 · EOQ
Bodyvision Medical , Ltd.
Ear, Nose, Throat · 212d