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
59881–59904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2007
ANTLIA II SUCTION PUMP SYSTEM
K070904 · OMP
Innovative Therapies, Inc.
General & Plastic Surgery · 11d
Cleared Apr 12, 2007
BIODUCT
K053492 · MAI
Bioduct, LLC
Orthopedic · 483d
Cleared Apr 12, 2007
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
K061277 · NHA
Straumann USA
Dental · 339d
Cleared Apr 12, 2007
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N
K061896 · DQA
Mediaid, Inc.
Anesthesiology · 283d
Cleared Apr 12, 2007
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · LSR
DiaSorin, Inc.
Microbiology · 231d
Cleared Apr 12, 2007
MYOMO E100
K062631 · OAL
Myomo, Inc.
Physical Medicine · 219d
Cleared Apr 12, 2007
ENDOBUTTON DIRECT
K070167 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 84d
Cleared Apr 12, 2007
OSTEOFIX BONE VOID FILLER
K070220 · MQV
Calcitec, Inc.
Orthopedic · 79d
Cleared Apr 12, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K070367 · NKB
Endius, Inc.
Orthopedic · 63d
Cleared Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
K070454 · KTT
Howmedica Osteonics Corp.
Orthopedic · 55d
Cleared Apr 12, 2007
SMS GLUCOSE CONTROL, MODEL 2120061
K070649 · JJX
Spectrum Medical Supply, Inc.
Chemistry · 35d
Cleared Apr 12, 2007
MIRAGE CEDARS OPTION
K070683 · LLZ
Segami Corporation
Radiology · 31d
Cleared Apr 12, 2007
GC MI PASTE PLUS
K070854 · EJR
GC America, Inc.
Dental · 15d
Cleared Apr 11, 2007
HYPERVISOR VI CENTRAL MONITORING SYSTEM
K062194 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 254d
Cleared Apr 11, 2007
POWDERED LATEX SURGICAL GLOVE
K062797 · KGO
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 204d
Cleared Apr 11, 2007
STATIC CRANIOPLASTY ORTHOSIS
K063098 · OAN
Boston Brace Intl., Inc.
Neurology · 183d
Cleared Apr 11, 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K063701 · LPS
Teco Diagnostics
Chemistry · 119d
Cleared Apr 11, 2007
QUANTA LITE RNA POL III ELISA
K070066 · NYO
Inova Diagnostics, Inc.
Immunology · 93d
Cleared Apr 11, 2007
AMMONIA/ALCOHOL CONTROL SET
K070504 · JJY
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Apr 11, 2007
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY...
K070674 · NVP
Trudell Medical Intl.
Anesthesiology · 30d
Cleared Apr 11, 2007
EP-WORKMATE
K070706 · DQK
Ep Medsystems
Cardiovascular · 28d
Cleared Apr 11, 2007
NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL
K070778 · MOS
Neocoil
Radiology · 21d
Cleared Apr 11, 2007
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL...
K070782 · MSH
Survivair Respirators, LLC
General Hospital · 21d
Cleared Apr 11, 2007
TRIAL CABLE, 3009
K070847 · GZB
Advanced Neuromodulation Systems
Neurology · 14d