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
39049–39072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726 · OZN
Primeradx
Microbiology · 91d
Cleared Nov 29, 2013
PIEZOSURGERY FLEX
K132848 · JDX
Mectron S.P.A.
Orthopedic · 79d
Cleared Nov 29, 2013
LESSRAY
K132970 · OWB
Saferay Spine, LLC
Radiology · 67d
Cleared Nov 29, 2013
TRANQUILL BARBED DEVICE
K133420 · NEW
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 21d
Cleared Nov 27, 2013
SPECULAR MICROSCOPE CEM-530
K130565 · NQE
Nidek Co., Ltd.
Ophthalmic · 268d
Cleared Nov 27, 2013
ROGS
K131016 · CAW
Molecular Products , Ltd.
Anesthesiology · 230d
Cleared Nov 27, 2013
ARCHON ANTERIOR CERVICAL PLATE SYSTEM
K131025 · KWQ
Nuvasive, Inc.
Orthopedic · 229d
Cleared Nov 27, 2013
GENESIS LED WANDS
K131142 · GEX
Genesis Biosystems, Inc.
General & Plastic Surgery · 218d
Cleared Nov 27, 2013
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC...
K131383 · GWQ
Advanced Brain Monitoring, Inc.
Neurology · 197d
Cleared Nov 27, 2013
JUSHA-M52C MEDICAL DISPLAY
K131390 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 197d
Cleared Nov 27, 2013
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591 · HWC
Pega Medical, Inc.
Orthopedic · 180d
Cleared Nov 27, 2013
SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
K132201 · LYZ
Zibo Intco Medical Products Co., Ltd.
General Hospital · 134d
Cleared Nov 27, 2013
MYLABSEVEN, MYLABALPHA
K132231 · IYN
Esaote, S.P.A.
Radiology · 132d
Cleared Nov 27, 2013
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON...
K132658 · FZP
Teleflex Medical
General & Plastic Surgery · 93d
Cleared Nov 27, 2013
E-CUBE 7
K132687 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 91d
Cleared Nov 27, 2013
ESPIN SYSTEM
K133061 · HRX
Nlt Spine, Ltd.
Orthopedic · 61d
Cleared Nov 27, 2013
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086 · NKB
Zimmer Spine, Inc.
Orthopedic · 58d
Cleared Nov 27, 2013
ZIP MIS INTERSPINOUS FUSION SYSTEM
K133091 · PEK
Aurora Spine
Orthopedic · 58d
Cleared Nov 27, 2013
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
K133282 · KRD
Reverse Medical Corporation
Cardiovascular · 33d
Cleared Nov 27, 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
K133329 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 26, 2013
SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
K122024 · FRC
Spsmedical Supply Corp.
General Hospital · 503d
Cleared Nov 26, 2013
PRODIGY CHOICE
K122340 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 481d
Cleared Nov 26, 2013
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · HSD
Exactech, Inc.
Orthopedic · 204d
Cleared Nov 26, 2013
SOLAX
K131302 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 203d