Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
40537–40560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 14, 2013
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247 · MEB
Mfs - Medical Flow Systems, Ltd.
General Hospital · 105d
Cleared Aug 14, 2013
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425 · OLO
Medtronic Navigation, Inc.
Orthopedic · 89d
Cleared Aug 14, 2013
ACE -GT REAGENT
K131515 · KLI
Alfa Wassermann
Chemistry · 78d
Cleared Aug 14, 2013
GLIDE DEVICE
K131870 · OHT
Home Skinovations , Ltd.
General & Plastic Surgery · 51d
Cleared Aug 14, 2013
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
K131951 · OVE
X-Spine Systems, Inc.
Orthopedic · 48d
Cleared Aug 14, 2013
PROADENO+ ASSAY
K132159 · OCC
Gen-Probe Prodesse, Inc.
Microbiology · 33d
Cleared Aug 14, 2013
PRO HMPV+ ASSAY
K132200 · OEM
Gen-Probe Prodesse, Inc.
Microbiology · 29d
Cleared Aug 13, 2013
ACE MONOPOLAR ATTACHMENT
K123061 · GEI
Bioeconeer, Inc.
General & Plastic Surgery · 316d
Cleared Aug 13, 2013
PRECISE SHP DIODE LASER
K123443 · GEX
CAO Group, Inc.
General & Plastic Surgery · 278d
Cleared Aug 13, 2013
HOPER PTCA BALLOON CATHETER
K123473 · LOX
Lepu Medical Technology (Beijing)...
Cardiovascular · 273d