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

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175,820 results
46753–46776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2011
HAIRMAX DUAL 12
K111714 · OAP
Lexington International, LLC
General & Plastic Surgery · 57d
Cleared Aug 15, 2011
MEDILED MINI
K103735 · LBI
Medix I.C.S.A.
General Hospital · 236d
Cleared Aug 15, 2011
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · MQM
Siemens Healthcare Diagnostics
Chemistry · 196d
Cleared Aug 15, 2011
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
K111176 · GWO
Osteomed LP
Neurology · 110d
Cleared Aug 15, 2011
CRANIAL REMOLDING ORTHOSIS
K111247 · MVA
Orthotic Care Services, Llp
Neurology · 104d
Cleared Aug 15, 2011
ION HEALTH USB INSTA-SCAN THERMOMETER
K111974 · FLL
Taidoc Technology Corporation
General Hospital · 34d
Cleared Aug 12, 2011
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK...
K102120 · CBK
Hsiner Co., Ltd.
Anesthesiology · 379d
Cleared Aug 12, 2011
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K102330 · MLR
STERIS Corporation
General Hospital · 360d
Cleared Aug 12, 2011
BRIVO XR385
K103448 · KPR
Ge Medical Systems, LLC
Radiology · 261d
Cleared Aug 12, 2011
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
K103699 · NUN
Exactech, Inc.
Dental · 235d
Cleared Aug 12, 2011
ACCUSOM
K110486 · MNR
Novasom, Inc.
Anesthesiology · 171d
Cleared Aug 12, 2011
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
K110580 · NHA
Straumann USA
Dental · 164d
Cleared Aug 12, 2011
NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
K110627 · LJS
Marvao Medical Devices, Ltd.
General Hospital · 161d
Cleared Aug 12, 2011
NITRILE POWDER FREE EXAMINATION GLOVES
K110758 · LZA
Hartalega Sdn Bhd
General Hospital · 147d
Cleared Aug 12, 2011
SENTRYSUITE PRODUCT LINE
K111053 · BTY
Carefusion Germany 234 GmbH
Anesthesiology · 119d
Cleared Aug 12, 2011
SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN,...
K111300 · LZA
Pt Mahakarya Inti Buana
General Hospital · 95d
Cleared Aug 12, 2011
ISROBOT MONA LISA
K111347 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 91d
Cleared Aug 12, 2011
ZIRPRIME
K111383 · EIH
Noritake Co., Inc.
Dental · 87d
Cleared Aug 12, 2011
VITEK 2 AST-ST LINEZOLID
K111599 · LON
bioMerieux, Inc.
Microbiology · 65d
Cleared Aug 12, 2011
KIDS ROCK 3 CHAIR
K111739 · IOR
Pride Mobility Products Corp.
Physical Medicine · 52d
Cleared Aug 12, 2011
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
K112034 · IKT
Carefusion 209, Inc.
Neurology · 28d
Cleared Aug 12, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · KRD
Boston Scientific Corp
Cardiovascular · 21d
Cleared Aug 11, 2011
LUCINA MODEL MELODI
K102516 · HGX
Genadyne Biotechnologies, Inc.
Obstetrics & Gynecology · 343d
Cleared Aug 11, 2011
EEVATM PETRI DISH
K103028 · MQK
Auxogyn, Inc.
Obstetrics & Gynecology · 302d