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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
81361–81384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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