FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80233–80256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2000
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
K002775 · HRS
Hand Innovations, Inc.
Orthopedic · 90d
Cleared Dec 05, 2000
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
K002782 · LLZ
Nuclear Diagnostics AB
Radiology · 90d
Cleared Dec 05, 2000
FIXION INTERLOCKING NAIL (FIXION IL NAIL)
K002783 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Dec 05, 2000
MEDIPRIME
K002894 · LLZ
Algotec Systems, Ltd.
Radiology · 78d
Cleared Dec 05, 2000
JEWEL CAST III
K003037 · EJH
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Dec 05, 2000
GOLD CORE II
K003039 · EJH
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Dec 05, 2000
UBM PLUS, MODEL P45
K003141 · IYO
Paradigm Medical Industries, Inc.
Radiology · 56d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · DJG
Dade Behring, Inc.
Toxicology · 53d
Cleared Dec 05, 2000
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
K003291 · JZO
Bayer Diagnostics Corp.
Immunology · 46d
Cleared Dec 05, 2000
ALBUMIN
K003327 · CIX
Jas Diagnostics, Inc.
Chemistry · 42d
Cleared Dec 05, 2000
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
K003582 · FRN
Fluidsense Corp.
General Hospital · 15d
Cleared Dec 04, 2000
TKD SCALERS
K000846 · ELC
Orasystems
Dental · 264d
Cleared Dec 04, 2000
MODIFICATION TO INTRALASE 600C LASER KERATOME
K001211 · GEX
Intra Lase Corp.
General & Plastic Surgery · 234d
Cleared Dec 04, 2000
XPS 3000 SYSTEM
K002224 · ERL
Medtronic Xomed
Ear, Nose, Throat · 133d
Cleared Dec 04, 2000
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 122d
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