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
65665–65688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2005
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A
K051500 · IYO
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Jun 16, 2005
ENERGEX
K042686 · NHH
Energex Systems, Inc.
Neurology · 260d
Cleared Jun 16, 2005
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
K050910 · FAS
Roei Medical Technologies, Ltd.
Gastroenterology & Urology · 66d
Cleared Jun 16, 2005
ACCU02 SYSTEM
K051007 · NFB
Miti Corp.
Anesthesiology · 57d
Cleared Jun 16, 2005
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K051247 · FCG
Medi-Globe Corp.
Gastroenterology & Urology · 31d
Cleared Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · KNW
Boston Scientific Corp
Gastroenterology & Urology · 22d
Cleared Jun 16, 2005
EYE CUP, STERILE 1 AND NON STERILE
K051414 · LXQ
Tollot Pty.Ltd.(Aaxis Pacific)
Ophthalmic · 16d
Cleared Jun 16, 2005
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · JOH
Mallinckrodt Medical
Anesthesiology · 15d
Cleared Jun 16, 2005
GE VIVID 7 WITH OR WITHOUT SUFFIX
K051449 · IYN
GE Medical Systems
Radiology · 14d
Cleared Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · FED
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared Jun 15, 2005
BIODERM SCIENCES WOUND HEALING SPRAY
K042084 · FRO
Bioderm Sciences, Inc.
General & Plastic Surgery · 316d
Cleared Jun 15, 2005
PALOMAR LUXIR HANDPIECE
K050370 · ILY
Palomar Medical Technologies, Inc.
Physical Medicine · 121d
Cleared Jun 15, 2005
ADVIA IMS LITHIUM ASSAY
K050374 · NDW
Bayer Healthcare, LLC
Chemistry · 121d
Cleared Jun 15, 2005
MEDICON IMF-ORION SCREWS
K050478 · DZE
Medicon EG
Dental · 111d
Cleared Jun 15, 2005
DIADEXUS PLAC TEST
K050523 · NOE
Diadexus, Inc.
Chemistry · 105d
Cleared Jun 15, 2005
BIPAP AUTO
K050759 · BZD
Respironics, Inc.
Anesthesiology · 83d
Cleared Jun 15, 2005
6 FR DL POWERPICC CATHETER
K050931 · LJS
C.R. Bard, Inc.
General Hospital · 62d
Cleared Jun 15, 2005
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
K050998 · FMF
Confluent Surgical,Inc
General Hospital · 56d
Cleared Jun 15, 2005
SET
K051008 · EMA
Southern Dental Industries, Ltd.
Dental · 56d
Cleared Jun 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML
K051109 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jun 15, 2005
GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE,...
K051267 · NPK
W.L. Gore & Associates, Inc.
Dental · 30d
Cleared Jun 15, 2005
MODIFICATION TO: SECTRA IDS5 WORKSTATION
K051315 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Jun 15, 2005
LYSUS INFUSION SYSTEM
K051319 · QEY
Ekos Corp.
Cardiovascular · 26d
Cleared Jun 15, 2005
WEBPAX, MODEL 200
K051325 · LLZ
Heart Imaging Technologies, LLC
Radiology · 26d