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
33169–33192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2016
Ez3D Plus
K152746 · LLZ
Ewoosoft Co., Ltd.
Radiology · 102d
Cleared Dec 31, 2015
Ascent 3D
K150585 · EBZ
CAO Group, Inc.
Dental · 297d
Cleared Dec 31, 2015
Ageless Health Medical Digital Thermometer
K152508 · FLL
Dongguan Ageless Health Industrial...
General Hospital · 120d
Cleared Dec 31, 2015
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
K152644 · HKY
Keeler Limited
Ophthalmic · 106d
Cleared Dec 31, 2015
Giraffe Incubator Carestation CS1
K152809 · FMZ
Ohmeda Medical, A Division of...
General Hospital · 94d
Cleared Dec 31, 2015
Visions PV .035 Digital IVUS Catheter
K153094 · OBJ
Volcano Corporation
Cardiovascular · 66d
Cleared CT Dec 31, 2015
Internal Joint Stabilizer - Elbow
K153208 · OZI
Skeletal Dynamics, LLC
Orthopedic · 56d
Cleared Dec 30, 2015
Navigator Aesthetic Delivery System
K151255 · FRN
Carticept Medical, Inc.
General Hospital · 232d
Cleared Dec 30, 2015
HumanPen Ergo II
K151686 · FMF
Eli Lilly and Company, Inc.
General Hospital · 190d
Cleared Dec 30, 2015
Bio2 Fusion Implant System
K151876 · HTY
Bio2 Technologies, Inc.
Orthopedic · 174d
Cleared Dec 30, 2015
Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm...
K151907 · KTT
Zimmer, Inc.
Orthopedic · 170d
Cleared Dec 30, 2015
MedActive Oral Gel and Spray
K152201 · LFD
Medactive Oral Pharmaceuticals, LLC
Dental · 146d
Cleared Dec 30, 2015
VITA VM LC Flow
K152373 · EBF
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 131d
Cleared Dec 30, 2015
Beacon Fine Needle Fiducial System
K152586 · NEU
Covidien, LLC
General & Plastic Surgery · 111d
Cleared Dec 30, 2015
SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
K152889 · OLP
Biorenew Labs, LLC
General & Plastic Surgery · 91d
Cleared Dec 30, 2015
Arsenal Spinal Fixation System
K152968 · NKB
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Dec 30, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K153463 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 29, 2015
SpectraShield 9500 Surgical N95 Respirator
K150729 · ONT
Nexera Medical, Inc.
General Hospital · 284d
Cleared Dec 29, 2015
Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
K150841 · NUC
Laclede, Inc.
Obstetrics & Gynecology · 274d
Cleared Dec 29, 2015
iHearTest
K151025 · EWO
Ihear Medical, Inc.
Ear, Nose, Throat · 257d
Cleared Dec 29, 2015
VisualEyes
K152112 · GWN
Interacoustics A/S
Neurology · 153d
Cleared Dec 29, 2015
HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE...
K152860 · GEI
Conmed Corporation
General & Plastic Surgery · 90d
Cleared Dec 29, 2015
Traxcess Pro 14 Guidewire
K153053 · MOF
MicroVention, Inc.
Neurology · 70d
Cleared Dec 28, 2015
Intellijoint HIP(tm) System
K151364 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 221d