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
39097–39120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Nov 25, 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K132498 · DYB
Medcomp (Medical Components, Inc.)
Cardiovascular · 108d
Cleared Nov 25, 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504 · KWP
Corelink, LLC
Orthopedic · 105d
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
K132544 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 104d
Cleared Nov 25, 2013
BLACK COLOURED CONDOM
K132597 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 98d
Cleared Nov 25, 2013
CD HORIZON SPINAL SYSTEM
K132639 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Nov 25, 2013
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K132884 · NKB
Zimmer Spine, Inc.
Orthopedic · 73d
Cleared Nov 25, 2013
CHARRUAPACS SYSTEM
K133357 · LLZ
Charruasoft SA
Radiology · 25d
Cleared Nov 22, 2013
BREATH SHAKE
K121587 · BYI
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 540d
Cleared Nov 22, 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
K123090 · NBW
General Life Biotechnology Co., Ltd.
Chemistry · 417d
Cleared Nov 22, 2013
CLARITY LPC LASER SYSTEM
K130199 · GEX
Lutronic Corporation
General & Plastic Surgery · 298d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · NQN
Ventana Medical Systems, Inc.
Pathology · 268d
Cleared Nov 22, 2013
REDSENSE ALARM SYSTEM
K130554 · ODX
Redsense Medical AB
Gastroenterology & Urology · 263d
Cleared Nov 22, 2013
V-STICK VASCULAR ACCESS SET
K130730 · DYB
Argon Medical
Cardiovascular · 249d
Cleared Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
K131482 · DQY
MicroVention, Inc.
Cardiovascular · 183d
Cleared Nov 22, 2013
PC ECG
K131819 · DPS
Edan Instruments, Inc.
Cardiovascular · 155d
Cleared Nov 22, 2013
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
K131826 · LYZ
Jiangsu Toptouch Glove Co., Ltd.
General Hospital · 155d
Cleared Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
K132119 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 22, 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189 · LXB
Sophono, Inc.
Ear, Nose, Throat · 130d
Cleared Nov 22, 2013
SP-FIX SPINOUS PROCESS FIXATION PLATE
K132191 · PEK
Globus Medical, Inc.
Orthopedic · 130d
Cleared Nov 22, 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE...
K132288 · NBW
I-Sens, Inc.
Chemistry · 122d
Cleared Nov 22, 2013
EASYCARE ONLINE
K132371 · MNS
Resmed, Ltd.
Anesthesiology · 115d
Cleared Nov 22, 2013
PIEZON 150
K132443 · ELC
E.M.S Electro Medical Systems S.A
Dental · 108d