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

Filters: Cleared only ×
176,076 results
65185–65208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2005
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)
K052109 · IYN
Sonosite,Inc.
Radiology · 7d
Cleared Aug 10, 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250 · LPN
Ciba Vision Corporation
Ophthalmic · 188d
Cleared Aug 10, 2005
100W CERALAS D 980 LASER SYSTEM, MODEL D100
K050824 · GEX
Biolitec, Inc.
General & Plastic Surgery · 132d
Cleared Aug 10, 2005
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
K051479 · KRO
Biomet Manufacturing, Inc.
Orthopedic · 68d
Cleared Aug 10, 2005
SBI K-WIRES
K051605 · HTY
Small Bone Innovations, LLC
Orthopedic · 55d
Cleared Aug 10, 2005
CHARLOTTE COMPRESSION PLATE
K051908 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Aug 10, 2005
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
K051955 · QSY
Z-Medica Corporation
General & Plastic Surgery · 22d
Cleared Aug 10, 2005
PILONPLATE WITH ANGULAR STABILITY
K052011 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 16d
Cleared Aug 09, 2005
MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX...
K040428 · NUC
R & K International Cosmetics
Obstetrics & Gynecology · 537d
Cleared Aug 09, 2005
GEN-PROBE APTIMA COMBO 2 ASSAY
K043224 · LSL
Gen-Probe, Inc.
Microbiology · 260d
Cleared Aug 09, 2005
Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
K050182 · CGA
Biomedix, Inc.
Chemistry · 194d
Cleared Aug 09, 2005
OMNILUX REVIVE AND OMNILUX PLUS
K050216 · GEX
Photo Therapeutics Limited
General & Plastic Surgery · 190d
Cleared Aug 09, 2005
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
K050446 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 168d
Cleared Aug 09, 2005
SILENT PARTNER SERIES OSA APPLIANCES
K051014 · LRK
Dreamwrx Dental Laboratory
Dental · 110d
Cleared Aug 09, 2005
BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM
K051368 · DXN
Schiller AG
Cardiovascular · 76d
Cleared Aug 09, 2005
VTRAC EXCIMER LAMP SYSTEM
K051428 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 69d
Cleared Aug 09, 2005
COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV
K051434 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 69d
Cleared Aug 09, 2005
ENDOSCOPIC APPLICATOR
K051732 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 42d
Cleared Aug 09, 2005
ORTHOSCAN, ORTHOSCAN HD
K051754 · OXO
Orthoscan, Inc.
Radiology · 41d
Cleared Aug 09, 2005
CLEARFIL TRI-S BOND SINGLE DOSE
K051796 · KLE
Kuraray Medical Kurashiki Plant
Dental · 35d
Cleared Aug 09, 2005
FREESTYLE CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K051802 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 35d
Cleared Aug 09, 2005
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
K051941 · MUJ
Accuray, Inc.
Radiology · 22d
Cleared Aug 09, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · KPR
Ge Healthcare
Radiology · 20d
Cleared Aug 09, 2005
SYNGO CIRCULATION
K052029 · JAK
Siemens AG Medical Solutions
Radiology · 13d