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
39937–39960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2013
INTELLIVUE PATIENT MONITOR
K131829 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 57d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · LJS
Cook, Inc.
General Hospital · 21d
Cleared Aug 15, 2013
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
K122181 · NBW
Visgeneer, Inc.
Chemistry · 388d
Cleared Aug 15, 2013
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
K123766 · FMF
Novo Nordisk, Inc.
General Hospital · 251d
Cleared Aug 15, 2013
ANYONETM INTERNAL IMPLANT SYSTEM
K123988 · DZE
Megagen Implant Co., Ltd.
Dental · 232d
Cleared Aug 15, 2013
GYMFORM ABS-A-ROUND
K130074 · NGX
Well Brain International , Ltd.
Physical Medicine · 213d
Cleared Aug 15, 2013
GMK HINGE
K130299 · KRO
Medacta International
Orthopedic · 189d
Cleared Aug 15, 2013
KINEX BIOACTIVE
K130392 · MQV
Globus Medical, Inc.
Orthopedic · 181d
Cleared Aug 15, 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · DYB
Medical Components, Inc.
Cardiovascular · 155d
Cleared Aug 15, 2013
DYNASENSE SYSTEM
K130752 · KMI
Centauri Medical, Inc.
General Hospital · 149d
Cleared Aug 15, 2013
LVIVO EF SYSTEM
K130779 · LLZ
Diacardio, Ltd.
Radiology · 147d
Cleared Aug 15, 2013
ORTHOHELIX STAPLE SYSTEM
K130832 · JDR
Orthohelix Surgical Designs, Inc.
Orthopedic · 142d
Cleared Aug 15, 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
K131063 · DQY
St Jude Medical
Cardiovascular · 121d
Cleared Aug 15, 2013
AMECO SHEATH INTRODUCER
K131144 · DYB
Ameco Medical Industries
Cardiovascular · 114d
Cleared Aug 15, 2013
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
K131351 · CJE
Alfa Wassermann Diagnostic...
Chemistry · 97d
Cleared Aug 15, 2013
CONTRAST CONSERVATION SYSTEM
K131478 · DXT
Osprey Medical, Inc.
Cardiovascular · 85d
Cleared Aug 15, 2013
ORTHOVISION
K131570 · LLZ
Ewoosoft Co., Ltd.
Radiology · 77d
Cleared Aug 15, 2013
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL...
K132072 · NBW
Nipro Diagnostics, Inc.
Chemistry · 43d
Cleared Aug 15, 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Aug 14, 2013
AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
K123882 · DXN
Ageless Health Industrial
Cardiovascular · 240d
Cleared Aug 14, 2013
MERON APPLICATION CAPSULES
K130421 · EMA
Voco GmbH
Dental · 175d
Cleared Aug 14, 2013
LASSO NAV DUO LOOP CATHETER
K130602 · DRF
Biosense Webster, Inc.
Cardiovascular · 160d
Cleared Aug 14, 2013
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
K130693 · ELC
Aseptico, Inc.
Dental · 153d
Cleared Aug 14, 2013
C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K130948 · ODP
Southern Spine, LLC
Orthopedic · 131d