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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80761–80784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2000
ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL...
K002749 · FDF
The Olympus Optical Co.
Gastroenterology & Urology · 90d
Cleared Dec 04, 2000
SPARTAN A-10
K002753 · ELC
Spartan Ultrasonics, Inc.
Dental · 90d
Cleared Dec 04, 2000
NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
K002755 · LRN
T. Korossurgical Instruments Corp.
Orthopedic · 90d
Cleared Dec 04, 2000
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
K002761 · FJI
Fresenius Medical Care North America
Gastroenterology & Urology · 90d
Cleared Dec 04, 2000
SCITON IMAGE HAIR REMOVAL LASER
K002853 · GEX
Sciton, Inc
General & Plastic Surgery · 82d
Cleared Dec 04, 2000
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
K002884 · GEX
Fotona D.D.
General & Plastic Surgery · 80d
Cleared Dec 04, 2000
FLUOROLAB PLUS
K002893 · HAW
Z-Kat, Inc.
Neurology · 77d
Cleared Dec 04, 2000
ACETABULAR PLATES
K002941 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 74d
Cleared Dec 04, 2000
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
K002987 · GEI
Xomed, Inc.
General & Plastic Surgery · 70d
Cleared Dec 04, 2000
INFUSOMAT P
K003029 · FRN
B.Braun Medical, Inc.
General Hospital · 67d
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100...
K003245 · FOZ
Baxter Healthcare Corp
General Hospital · 48d
Cleared Dec 04, 2000
FERMIT PLUS
K003374 · EBG
Ivoclar North America, Inc.
Dental · 35d
Cleared Dec 04, 2000
FERMIT N PLUS
K003377 · EBG
Ivoclar North America, Inc.
Dental · 35d
Cleared Dec 04, 2000
CLEARGLIDE PRECISION BIPOLAR DEVICE
K003587 · GEI
Ethicon, Inc.
General & Plastic Surgery · 13d
Cleared Dec 04, 2000
U1 HIP SYSTEM
K994078 · LPH
United Orthopedic Corp.
Orthopedic · 368d
Cleared Dec 01, 2000
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · IYO
Acuson Corp.
Radiology · 84d
Cleared Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
K003110 · LJS
Medcomp
General Hospital · 58d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Dec 01, 2000
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · LIT
NuMED, Inc.
Cardiovascular · 43d
Cleared Dec 01, 2000
WIRECLIP TORQUER
K003398 · DQX
Boston Scientific Corporation...
Cardiovascular · 30d
Cleared Dec 01, 2000
DEPUY C-STEM SYSTEM
K003421 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · FIB
Fresenius Medical Care North America
Gastroenterology & Urology · 25d
Cleared Dec 01, 2000
PENTRA 5D
K003534 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d