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
36217–36240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2014
RENOVOCATH RC120
K141175 · MJN
Renovorx, Inc.
Cardiovascular · 171d
Cleared Oct 24, 2014
OPTON PRO
K141564 · ILY
Zimmer Medizinsystems GmbH
Physical Medicine · 134d
Cleared Oct 24, 2014
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · HTY
Wrightmedicaltechnologyinc
Orthopedic · 121d
Cleared Oct 24, 2014
NEPHROS DSU-H, NEPHROS SSU-H
K141731 · NHV
Nephros, Inc.
Gastroenterology & Urology · 119d
Cleared Oct 24, 2014
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
K141759 · MMK
Oak Ridge Products, LLC
General Hospital · 115d
Cleared Oct 24, 2014
STALIF CTI, STALIF C
K142079 · OVE
Centinel Spine, Inc.
Orthopedic · 85d
Cleared Oct 24, 2014
ELECYS CMV IGM IMMUNOASSAY
K142133 · LFZ
Roche Diagnostics
Microbiology · 81d
Cleared Oct 24, 2014
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm...
K142574 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 42d
Cleared Oct 24, 2014
CrossCLIP Implant System
K142727 · JDR
Orthodiscovery Group, LLC(D.B.A....
Orthopedic · 31d
Cleared Oct 24, 2014
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K142784 · DTZ
Medtronic, Inc.
Cardiovascular · 28d
Cleared Oct 23, 2014
SUPERNOVA C5 MRI SYSTEM
K131737 · LNH
Liaoning Kampo Medical System Co., Ltd.
Radiology · 497d
Cleared Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
K133157 · DRY
Medtronic, Inc.
Cardiovascular · 371d
Cleared Oct 23, 2014
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM
K140205 · CAC
Teleflexmedical, Inc.
Anesthesiology · 269d
Cleared Oct 23, 2014
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K140754 · HEX
CooperSurgical, Inc.
Obstetrics & Gynecology · 211d
Cleared Oct 23, 2014
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
K141125 · EGS
Handpiece Headquarters
Dental · 175d
Cleared Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
K141325 · HKI
Topcon Corp.
Ophthalmic · 156d
Cleared Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 155d
Cleared Oct 23, 2014
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560 · FTL
Ethicon, Inc.
General & Plastic Surgery · 133d
Cleared Oct 23, 2014
HEMOPORE
K141816 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 108d
Cleared Oct 23, 2014
RAYSTATION
K141860 · MUJ
Raysearch Laboratories AB
Radiology · 105d
Cleared Oct 23, 2014
ABACUS (TM) SPACER SYSTEM
K142101 · MAX
Spine Wave, Inc.
Orthopedic · 83d
Cleared Oct 23, 2014
Vasc Band hemostat
K142359 · DXC
Lepu Medical Technology (Beijing)...
Cardiovascular · 59d
Cleared Oct 23, 2014
Flexible Video-Uretero-Choledochoscope System
K142556 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 23, 2014
Stryker Precision HD Camera System
K142603 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 38d