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
33193–33216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2015
PediatrOS RigidTack/FlexTack
K151762 · JDR
Merete Medical GmbH
Orthopedic · 182d
Cleared Dec 28, 2015
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera...
K152951 · KCT
Paragon Medical, Inc.
General Hospital · 83d
Cleared Dec 28, 2015
Asnis JFX System
K153154 · HWC
Stryker Trauma AG
Orthopedic · 56d
Cleared Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
K153158 · FPA
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Dec 24, 2015
Myray- HYPERION X5
K152162 · MUH
Cefla S.C.
Radiology · 143d
Cleared Dec 24, 2015
MAGNETOM Amira
K152283 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Dec 24, 2015
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential...
K152542 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 111d
Cleared Dec 24, 2015
BrainPort V100
K152851 · PIC
Wicab, Inc.
Ophthalmic · 86d
Cleared Dec 24, 2015
CareView 1800L
K153492 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 20d
Cleared Dec 23, 2015
BTM Wound Dressing
K142879 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 447d
Cleared Dec 23, 2015
L-Mesitran Dressing Family II- Soft and Tulle
K150676 · FRO
Theo Manufacturing BV
General & Plastic Surgery · 282d
Cleared Dec 23, 2015
ENDOPLUS hand-held laparoscopic instruments
K151567 · HFI
Endoplus
Obstetrics & Gynecology · 196d
Cleared Dec 23, 2015
Medical Diode Laser Systems
K151890 · GEX
Wuhan Gigaa Optronics Technology Co.,...
General & Plastic Surgery · 166d
Cleared Dec 23, 2015
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
K152047 · KWS
Ascension Orthopedics
Orthopedic · 153d
Cleared Dec 23, 2015
2-in-1 Abdominal Muscle Training & Back Pain Relief System
K152128 · NUH
Tohkai Precision Electrical...
Neurology · 145d
Cleared Dec 23, 2015
Expression MR400 MRI Patient Monitoring System
K152330 · MWI
Invivo Corporation
Cardiovascular · 127d
Cleared Dec 23, 2015
SalivaMAX
K152406 · LFD
Forward Science, LLC
Dental · 120d
Cleared Dec 23, 2015
Solitaire Platinum Revascularization Device
K153071 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 62d
Cleared CT Dec 22, 2015
BONDEASE TOPICAL SKIN ADHESIVE
K141157 · MPN
Optmed, Inc.
General & Plastic Surgery · 596d
Cleared Dec 22, 2015
New Medax Biopsy Systems
K142125 · KNW
Medax Srl Unipersonale
Gastroenterology & Urology · 505d
Cleared Dec 22, 2015
ADVIA Centaur Toxoplasma M (Toxo M)
K142826 · LGD
Siemens Healthcare Diagnostics, Inc.
Microbiology · 448d
Cleared Dec 22, 2015
NeoLas
K150664 · GEX
Sheaumann Laser, Inc.
General & Plastic Surgery · 281d
Cleared Dec 22, 2015
Cellvizio 100 Series System with Confocal Miniprobes
K150831 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 267d
Cleared Dec 22, 2015
RUBY STAR
K150997 · GEX
Bison Medical Co, Ltd.
General & Plastic Surgery · 251d