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
63529–63552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2006
HALUX IRIS EXAMINATION AND SURGICAL LAMP
K053364 · FTD
Waldmann Lighting
General & Plastic Surgery · 83d
Cleared Feb 23, 2006
LOOP RECORDER VITAPHONE, 3100 SERIES
K053378 · DXH
Tms Telemedizinische Systeme GmbH
Cardiovascular · 80d
Cleared Feb 23, 2006
FLEXISCOPE, MODELS 50MH AND 50 MHC
K053412 · FWF
Schoelly Imaging, Inc.
General & Plastic Surgery · 78d
Cleared Feb 23, 2006
BIO-MINI REVO SUTURE ANCHOR
K053561 · HWC
Conmed Linvatec
Orthopedic · 64d
Cleared Feb 23, 2006
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · HSX
Mako Surgical Corp.
Orthopedic · 50d
Cleared Feb 23, 2006
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
K060150 · IRN
Andante Medical Devices , Ltd.
Physical Medicine · 34d
Cleared Feb 23, 2006
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
K060253 · HWC
Regeneration Technologies, Inc.
Orthopedic · 22d
Cleared Feb 23, 2006
GI DENTSTAT
K060334 · EMA
Ultradent Products, Inc.
Dental · 14d
Cleared Feb 22, 2006
ISSYS DRUG FLOW MONITOR
K050783 · FLN
Integrated Sensing Systems, Inc.
General Hospital · 331d
Cleared Feb 22, 2006
PROCERA BRIDGE ALUMINA
K053050 · NHA
Nobel Biocare AB
Dental · 117d
Cleared Feb 22, 2006
PROCERA BRIDGE LAMINATE, MODEL 40-4002
K053068 · NHA
Nobel Biocare AB
Dental · 113d
Cleared Feb 22, 2006
PROCERA BRIDGE ZIRCONIA
K053125 · NHA
Nobel Biocare AB
Dental · 107d
Cleared Feb 22, 2006
OSSIX -PLUS
K053260 · NPL
Colbar Lifescience , Ltd.
Dental · 92d
Cleared Feb 22, 2006
POPMESH
K053424 · FTL
Caldera Medical, Inc.
General & Plastic Surgery · 76d
Cleared Feb 22, 2006
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
K053484 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 69d
Cleared Feb 22, 2006
BERRY FRUITY TEETHER
K053493 · KKO
Evenflo Company, Inc.
Dental · 69d
Cleared Feb 22, 2006
WAVELIGHT IDAS
K053604 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 57d
Cleared Feb 22, 2006
NASALGUARD
K053625 · NUP
Trutek Corp
Ear, Nose, Throat · 56d
Cleared Feb 22, 2006
CALDERA MESH
K060004 · FTL
Caldera Medical, Inc.
General & Plastic Surgery · 50d
Cleared Feb 22, 2006
DERMACYN WOUND CARE
K060113 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 36d
Cleared Feb 22, 2006
BOVIE BUTTON REMOTE HAND SWITCH
K060117 · GEI
Aaron Medical Industries
General & Plastic Surgery · 36d
Cleared Feb 22, 2006
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
K060259 · OWB
Ge Medical Systems, LLC
Radiology · 21d
Cleared Feb 22, 2006
TRANSET SYSTEM
K060283 · HTY
Bonutti Research, Inc.
Orthopedic · 19d
Cleared Feb 21, 2006
GENZYME OSOM INFLUENZA A & B TEST
K051244 · PSZ
Genzyme Corp.
Microbiology · 281d