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

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176,076 results
56233–56256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2008
SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
K081676 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Jul 01, 2008
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
K072901 · NTY
Amdl, Inc.
Immunology · 264d
Cleared Jul 01, 2008
STRESSGARD NIGHTGUARD
K072968 · OBR
Totalgard Corporation
Dental · 253d
Cleared Jul 01, 2008
MOBILE I.V. SYSTEMS 10,20,60
K080695 · FPA
Northwind Technologies, Corp.
General Hospital · 112d
Cleared Jul 01, 2008
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · DXO
Radi Medical Systems AB
Cardiovascular · 102d
Cleared Jul 01, 2008
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
K080915 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 01, 2008
CAPILLARYS URINE
K080916 · JKM
Sebia
Immunology · 90d
Cleared Jul 01, 2008
TLS FIXATION SYSTEM
K080974 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 88d
Cleared Jul 01, 2008
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205 · JDQ
Synthes (Usa)
Orthopedic · 63d
Cleared Jul 01, 2008
STARCERAM
K081263 · EIH
H.C. Starck Ceramics GmbH & Co.Kg
Dental · 57d
Cleared Jul 01, 2008
LASER IMAGER DRYPRO MODEL 873
K081637 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 20d
Cleared Jun 30, 2008
DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE...
K072854 · NBW
Tyson Bioresearch, Inc.
Chemistry · 269d
Cleared Jun 30, 2008
SENSEI CATHETER CONTROL SYSTEM
K073225 · DXX
Hansen Medical, Inc.
Cardiovascular · 228d
Cleared Jun 30, 2008
S-TEST CREATININE (CRE)
K080073 · JFY
Alfa Wassermann, Inc.
Chemistry · 171d
Cleared Jun 30, 2008
WATCHHALER
K080100 · NVP
Activaero America, Inc.
Anesthesiology · 168d
Cleared Jun 30, 2008
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
K080379 · HCG
Micrus Endovascular Corporation
Neurology · 138d
Cleared Jun 30, 2008
L-VARLOCK
K080537 · MAX
Kiscomedica S.A.
Orthopedic · 124d
Cleared Jun 30, 2008
NEB-90 LARGE VOLUME MEDICATION NEBULIZER
K080657 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 115d
Cleared Jun 30, 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
K081027 · LZA
Kimberly-Clark Corp.
General Hospital · 81d
Cleared Jun 30, 2008
APOLLO MINI IPL SYSTEM
K081219 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 61d
Cleared Jun 30, 2008
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · JGS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Jun 30, 2008
CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION
K081564 · MQP
Creaspine
Orthopedic · 26d
Cleared Jun 30, 2008
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
K081620 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 21d
Cleared Jun 27, 2008
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K071984 · GWM
Cma Microdialysis AB
Neurology · 344d