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
41497–41520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2013
DIAGNOSTIC ULTRASOUND SYSTEM
K123249 · IYN
Edan Instruments, Inc.
Radiology · 114d
Cleared Feb 08, 2013
PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
K123308 · JOW
Albahealth, LLC
Cardiovascular · 107d
Cleared Feb 08, 2013
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
K123488 · LZA
Puyang Linshi Health Co., Ltd.
General Hospital · 87d
Cleared Feb 08, 2013
OPTIMA CT520
K123596 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 79d
Cleared Feb 08, 2013
PROFEMUR TL CLASSIC HIP STEM
K123688 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Feb 08, 2013
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
K123799 · DJG
Psychemedics Corp.
Toxicology · 60d
Cleared Feb 08, 2013
4MP COLOR LCD MONITOR, RADIFORCE RX440
K130070 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared Feb 08, 2013
CORONIS FUSION 6MP
K130103 · LLZ
Barco N.V.
Radiology · 24d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · NBW
Lifescan, Inc.
Chemistry · 349d
Cleared Feb 07, 2013
M2 WRIST MRI SYSTEM
K120701 · LNH
Aspect Imaging, Ltd.
Radiology · 337d
Cleared Feb 07, 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
K120708 · NBW
Cilag GmbH International
Chemistry · 336d
Cleared Feb 07, 2013
GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
K120922 · IPF
Selectivemed Components, Inc.
Physical Medicine · 317d
Cleared Feb 07, 2013
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
K121050 · NGT
Becton, Dickinson & CO
General Hospital · 307d
Cleared Feb 07, 2013
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
K121818 · GXN
Oxford Performance Materials
Neurology · 232d
Cleared Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554 · NTH
Applied Spectral Imaging , Ltd.
Pathology · 170d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · DRC
St Jude Medical
Cardiovascular · 167d
Cleared Feb 07, 2013
TOXCUP DRUG SCREEN CUP
K122633 · LDJ
Branan Medical Corp.
Chemistry · 162d
Cleared Feb 07, 2013
SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
K122822 · NQW
Spectrum Spine, LLC
Orthopedic · 146d
Cleared Feb 07, 2013
COMPRESSYN STAPLE
K122871 · JDR
Dallen Medical, Inc.
Orthopedic · 141d
Cleared Feb 07, 2013
MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
K123206 · ODP
Maxim Surgical
Orthopedic · 118d
Cleared Feb 07, 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY...
K123216 · DPT
Aimago SA
Cardiovascular · 115d
Cleared Feb 07, 2013
SPINEOLOGY SPINOUS PROCESS PLATE
K123232 · KWP
Spineology, Inc.
Orthopedic · 114d
Cleared Feb 07, 2013
RELIANCE SPINAL SCREW SYSTEM
K123521 · MNI
Reliance Medical Systems, LLC
Orthopedic · 84d
Cleared Feb 07, 2013
XIPHOS
K123969 · MAX
Difusion Technologies
Orthopedic · 43d