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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
39961–39984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2013
MULTICHEM S PLUS / S PLUS (ASSAYED)
K132751 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 49d
Cleared Oct 22, 2013
OCCLUSION BALLOON CATHETER
K132990 · MJN
Boston Scientific Corp
Cardiovascular · 28d
Cleared Oct 22, 2013
IMMULITE 2000
K133128 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 21, 2013
NEO DENTA ZIRCONIA
K130198 · EIH
Neo Group Limited
Dental · 266d
Cleared Oct 21, 2013
BIOPLEX 2200 APLS IGM
K130528 · MID
Bio-Rad Laboratories
Immunology · 234d
Cleared Oct 21, 2013
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
K131630 · LIO
Puritan Medical Products, LLC
Microbiology · 139d
Cleared Oct 21, 2013
SWIFT AIR
K132013 · BZD
Resmed, Ltd.
Anesthesiology · 112d
Cleared Oct 21, 2013
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
K132181 · EZN
Olympus Surgical Technologies America
Gastroenterology & Urology · 98d
Cleared Oct 18, 2013
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
K122437 · MBI
Biomet Sports Medicine
Orthopedic · 434d
Cleared Oct 18, 2013
LENSTEC LC INJECTION SYSTEM
K122848 · MSS
Lenstec, Inc.
Ophthalmic · 395d
Cleared Oct 18, 2013
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF...
K130213 · LDJ
Lumiquick Diagnostics, Inc.
Chemistry · 262d
Cleared Oct 18, 2013
ASA ORAL APPLIANCES
K130504 · LRK
American Sleep Association
Dental · 233d
Cleared Oct 18, 2013
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K130684 · MKJ
Philips Medical Systems
Cardiovascular · 219d
Cleared Oct 18, 2013
CRANIAL MAP NEURO
K131214 · HAW
Stryker Corporate
Neurology · 172d
Cleared Oct 18, 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
K131663 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 133d
Cleared Oct 18, 2013
MULTIFUNCTIONAL SERIES
K131859 · ONF
Beijing Honkon Technologies Co., Ltd.
General & Plastic Surgery · 116d
Cleared Oct 18, 2013
PROVOX VEGA PUNCTURE SET
K131947 · EWL
Atos Medical AB
Ear, Nose, Throat · 113d
Cleared Oct 18, 2013
REMSTAR AUTO A-FLEX HT
K131982 · BZD
Respironics, Inc.
Anesthesiology · 112d
Cleared Oct 18, 2013
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET,...
K132096 · LDJ
Biophor Diagnostics, Inc.
Toxicology · 102d
Cleared Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · JHY
Roche Diagnostics
Chemistry · 64d
Cleared Oct 18, 2013
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · KRA
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 17, 2013
SAPPHIRE INFUSION PUMP
K123049 · FRN
Q Core Medical , Ltd.
General Hospital · 384d
Cleared Oct 17, 2013
NBM-200MP
K124041 · DQA
Orsense, Ltd.
Anesthesiology · 293d
Cleared Oct 17, 2013
RESPIGUIDE DELIVERY SYSTEM
K130378 · DQY
Respicardia
Cardiovascular · 245d