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
46825–46848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2011
IMPAX NEXT GENERATION
K111945 · LLZ
Agfa Healthcare N.V.
Radiology · 28d
Cleared Aug 05, 2011
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
K112054 · JAA
Toshiba Medical Systems Corporation,...
Radiology · 17d
Cleared Aug 05, 2011
ECG-6 SERIES ELECTROCARDIOGRAPH
K112135 · DPS
Advanced Instrumentations, Inc.
Cardiovascular · 10d
Cleared Aug 04, 2011
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
K110005 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 213d
Cleared Aug 04, 2011
UNITED UTF STEM
K110245 · LPH
United Orthopedic Corporation
Orthopedic · 189d
Cleared Aug 04, 2011
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
K110410 · GYC
Nihon Kohden Corp.
Neurology · 171d
Cleared Aug 04, 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
K111043 · OBJ
Boston Scientific Corp
Radiology · 111d
Cleared Aug 04, 2011
AESCULAP SIBD XP SPINAL SYSTEM
K111122 · OVD
Aesculap Implant Systems, Inc.
Orthopedic · 105d
Cleared Aug 04, 2011
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID...
K111372 · MSD
Covidien
Gastroenterology & Urology · 80d
Cleared Aug 04, 2011
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
K111387 · OCC
Iquum, Inc.
Microbiology · 79d
Cleared Aug 04, 2011
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
K111478 · NKB
Stryker Corporation
Orthopedic · 69d
Cleared Aug 04, 2011
MICROSCAN(R) MICROSTREP PLUS(R)
K111677 · LRG
Siemens Healthcare Diagnostics, Inc.
Microbiology · 50d
Cleared Aug 04, 2011
CORIN OPTIMOM MODULAR HEAD
K111911 · KWL
Corin USA
Orthopedic · 30d
Cleared Aug 03, 2011
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS...
K101934 · HSB
Medshape Solutions
Orthopedic · 387d
Cleared Aug 03, 2011
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
K102760 · LCX
Atlas Medical
Chemistry · 314d
Cleared Aug 03, 2011
TELEMEDCARE HEALTH MONITOR
K103796 · DRG
Telemedcare Pty, Ltd.
Cardiovascular · 219d
Cleared Aug 03, 2011
KNEEHAB XP
K110350 · GZJ
Bio-Medical Research, Ltd.
Neurology · 177d
Cleared Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
K110707 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 142d
Cleared Aug 03, 2011
TANDA MAX OTC SYSTEM
K110735 · OHS
Pharos Life Corporation
General & Plastic Surgery · 140d
Cleared Aug 03, 2011
BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
K111095 · ITI
Electro Kinetic Technologies, LLC
Physical Medicine · 105d
Cleared Aug 03, 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 97d
Cleared Aug 03, 2011
CONSTRUX EXTERNAL FIXATION DEVICE
K111376 · KTT
Ebi, LLC
Orthopedic · 79d
Cleared Aug 03, 2011
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
K111527 · OQO
Eragen Biosciences, Inc.
Microbiology · 63d
Cleared Aug 03, 2011
EKOSONIC ENDOVASCULAR SYSTEM
K111705 · QEY
Ekos Corporation
Cardiovascular · 47d