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
38233–38256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2014
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
K140263 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 30d
Cleared Mar 05, 2014
NMI PICC IV
K140266 · LJS
Navilyst Medical, Inc.
General Hospital · 30d
Cleared Mar 04, 2014
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT...
K131788 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 259d
Cleared Mar 04, 2014
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE,...
K132908 · IYE
Medtec, Inc.
Radiology · 168d
Cleared Mar 04, 2014
NOVOPORE DRESSING
K132936 · OMP
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 167d
Cleared Mar 04, 2014
RITHM ID ELECTROPHYSIOLOGY CATHETER
K133028 · DRF
Synaptic Medical Limited
Cardiovascular · 159d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117 · DXQ
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Mar 04, 2014
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED
K133339 · DZE
Zimmer Dental, Inc.
Dental · 125d
Cleared Mar 04, 2014
HEM-7320
K133383 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Mar 04, 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
K133472 · LPL
Souflon Pharmaceuticals, Ltd.
Ophthalmic · 112d
Cleared Mar 04, 2014
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
K133525 · HRS
Changzhou Dean Medical Instrument Co,...
Orthopedic · 109d
Cleared Mar 04, 2014
LIGHTHOUSE URINARY CATHETER
K140099 · EZL
Seedings Life Science Ventures, LLC
Gastroenterology & Urology · 47d
Cleared Mar 04, 2014
SONIC WINDOW
K140126 · IYO
Analogic Corporation
Radiology · 47d
Cleared Mar 03, 2014
IPM WOUND GEL BIO
K123193 · FRO
Glycobiosciences, Inc.
General & Plastic Surgery · 508d
Cleared Mar 03, 2014
SFI-ANCHOR
K130618 · NHA
Cendres & Metaux SA
Dental · 361d
Cleared Mar 03, 2014
VISICLEAR SMOKE EVACUATION SYSTEM
K131402 · FYD
Buffalo Filter Co., Inc.
General Hospital · 292d
Cleared Mar 03, 2014
MOERAE VEIN PREPARATION KIT
K131659 · GBX
Moerae Matrix, Inc.
General & Plastic Surgery · 270d
Cleared Mar 03, 2014
SKINTELL
K132800 · NQQ
Agfa Healthcare N.V.
General & Plastic Surgery · 178d
Cleared Mar 03, 2014
NXSTAGE SYSTEM ONE WITH NXVIEW
K133547 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 104d
Cleared Mar 03, 2014
AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE...
K133668 · HRS
Shoulder Options, Inc.
Orthopedic · 94d
Cleared Mar 03, 2014
HEARTSCAN SOFTWARE
K133937 · LLZ
Morpheus Imaging, Inc.
Radiology · 70d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · PDJ
Abbott Laboratories
Chemistry · 392d
Cleared Feb 28, 2014
JINTRONIX REHABILITATION SYSTEM (JRS)
K130847 · LXJ
Jintronix, Inc.
Physical Medicine · 339d
Cleared Feb 28, 2014
LERADO, POWER WHEELCHAIR
K130982 · ITI
Lerado Global (Macao Commercial...
Physical Medicine · 325d