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
55417–55440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2008
BARD 3DMAX MESH
K081010 · FTL
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 181d
Cleared Oct 07, 2008
ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED...
K081666 · NHA
Astra Tech, Inc.
Dental · 116d
Cleared Oct 07, 2008
STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
K081935 · IYE
Aktina Medical Physics Corp.
Radiology · 92d
Cleared Oct 07, 2008
SYNERGY SPINAL SYSTEM (6.35 POLARIS)
K081952 · NKB
Biomet Spine
Orthopedic · 90d
Cleared Oct 07, 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · MQV
Globus Medical, Inc.
Orthopedic · 43d
Cleared Oct 07, 2008
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
K082608 · NKB
Stryker Spine
Orthopedic · 29d
Cleared Oct 07, 2008
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
K082618 · NBW
Taidoc Technology Corporation
Chemistry · 28d
Cleared Oct 07, 2008
JUMAO MANUAL WHEELCHAIR
K082784 · IOR
Danyang Jumao Healthcare Equipment...
Physical Medicine · 14d
Cleared Oct 06, 2008
SEN-4100 ELECTRIC STIMULATOR
K071969 · GWF
Nihon Kohden America, Inc.
Neurology · 447d
Cleared Oct 06, 2008
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
K081478 · JJX
Bionostics, Inc.
Chemistry · 132d
Cleared Oct 06, 2008
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR,...
K081820 · DWF
Avalon Laboratories, LLC
Cardiovascular · 101d
Cleared Oct 06, 2008
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS...
K082032 · NKB
Abbott Spine, Inc.
Orthopedic · 81d
Cleared Oct 06, 2008
LYMPHA PRESS OPTIMAL, MODEL# 1201AP
K082149 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 68d
Cleared Oct 06, 2008
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
K082217 · LGZ
Arizant Healthcare, Inc.
General Hospital · 61d
Cleared Oct 06, 2008
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · JTN
Becton, Dickinson & CO
Microbiology · 56d
Cleared Oct 06, 2008
GRIND NO MORE
K082301 · OBR
Placontrol, Inc.
Dental · 55d
Cleared Oct 06, 2008
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661 · GTY
Princeton BioMeditech Corp.
Microbiology · 24d
Cleared Oct 06, 2008
COLOR LCD MONITOR
K082663 · LLZ
Eizo Nanao Corporation
Radiology · 24d
Cleared Oct 06, 2008
JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
K082664 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 24d
Cleared Oct 03, 2008
ML830TP
K080786 · ILY
Microlight Corporation of America
Physical Medicine · 197d
Cleared Oct 03, 2008
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
K080825 · OBH
Impedimed Pty , Ltd.
Gastroenterology & Urology · 193d
Cleared Oct 03, 2008
GORE TRI-LOBE BALLOON CATHETER
K081799 · DQY
W.L. Gore & Associates, Inc.
Cardiovascular · 100d
Cleared Oct 03, 2008
ENGSTROM CARESTATION, ENGSTROM PRO
K081842 · CBK
Datex-Ohmeda, Inc.
Anesthesiology · 95d
Cleared Oct 03, 2008
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
K081933 · DWF
Avalon Laboratories, LLC
Cardiovascular · 88d