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
54289–54312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2009
SMOOTHSHAPES
K083629 · NUV
Eleme Medical, Inc.
General & Plastic Surgery · 73d
Cleared Feb 19, 2009
MAC 800 RESTING ECG ANALYSIS SYSTEM
K090212 · DPS
Ge Medical Syst. Information...
Cardiovascular · 22d
Cleared Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · DQO
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Feb 19, 2009
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332,...
K090296 · KPT
Biodex Medical Systems, Inc.
Radiology · 13d
Cleared Feb 18, 2009
COTTONS 100% NATURAL COTTON TAMPONS
K080733 · HEB
Cottons Pty, Ltd.
Obstetrics & Gynecology · 341d
Cleared Feb 18, 2009
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
K081137 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 303d
Cleared Feb 18, 2009
QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE...
K082117 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 205d
Cleared Feb 18, 2009
ANATOMIC LOCKING PLATING SYSTEM
K082300 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 190d
Cleared Feb 18, 2009
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM]...
K082468 · KWY
Omni Life Science, Inc.
Orthopedic · 175d
Cleared Feb 18, 2009
EMS AIR-FLOW MASTER
K082791 · EFB
E.M.S Electro Medical Systems S.A
Dental · 148d
Cleared Feb 18, 2009
AXXION LIGHT GUIDE
K082992 · FST
Spinal Elements, Inc.
General & Plastic Surgery · 134d
Cleared Feb 18, 2009
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
K083252 · EBW
Dentalez Group, Stardental Division
Dental · 106d
Cleared Feb 18, 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32...
K083262 · LTT
Siemens Healthcare Diagnostics
Microbiology · 105d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 18, 2009
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
K083735 · JOM
Medtechs, LLC
Cardiovascular · 64d
Cleared Feb 18, 2009
GELPORT SINGLE INCISION ACCESS SYSTEM
K090275 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 14d
Cleared Feb 17, 2009
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
K082921 · MOT
Rad Source Technologies, Inc.
Radiology · 139d
Cleared Feb 17, 2009
PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
K083259 · LYZ
Tangshan Zhongying Plastic Products...
General Hospital · 105d
Cleared Feb 17, 2009
ECHELON C MRI SYSTEM
K083533 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 81d
Cleared Feb 17, 2009
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
K083639 · DQK
Ge Medical Systems Information...
Cardiovascular · 70d
Cleared Feb 17, 2009
THE IC-PRO SYSTEM, MODEL VERSION 3.2
K083745 · IZI
Paieon, Inc.
Radiology · 63d
Cleared Feb 17, 2009
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
K083855 · DYB
Acumen Medical, Inc.
Cardiovascular · 55d
Cleared Feb 17, 2009
TRIMIRA IDENTAFI 3000
K090135 · NXV
Remicalm, LLC
Dental · 27d
Cleared Feb 17, 2009
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123...
K090202 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 21d