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
33409–33432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 2015
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
K152632 · NKB
Stryker Corporation
Orthopedic · 78d
Cleared Dec 02, 2015
Lantern Delivery Microcatheter
K152840 · DQY
Penumbra, Inc.
Cardiovascular · 64d
Cleared Dec 02, 2015
Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18...
K153140 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 33d
Cleared Dec 02, 2015
Capiox Advance Hardshell Reservoir
K153143 · DTN
Terumo Cardiovascular Systems...
Cardiovascular · 33d
Cleared Dec 01, 2015
RX-FIX Mini Rail External Fixator
K150640 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 265d
Cleared Dec 01, 2015
Biodenta Customized Abutment - Titanium
K151295 · NHA
Biodenta Swiss AG
Dental · 200d
Cleared Dec 01, 2015
Gmate Origin Blood Glucose Monitoring System
K151658 · NBW
Philosys, Inc.
Chemistry · 165d
Cleared Dec 01, 2015
Video Colposcope
K151878 · HEX
Edan Instruments, Inc.
Obstetrics & Gynecology · 145d
Cleared Dec 01, 2015
3M Attest Rapid Readout Biological Indicator 1295
K152060 · FRC
3M Company
General Hospital · 130d
Cleared Dec 01, 2015
NuVent EM Sinus Dilation System
K152121 · LRC
Medtronic Xomed, Inc.
Ear, Nose, Throat · 124d
Cleared Dec 01, 2015
Glidesheath
K152173 · DYB
Terumo Medical Corporation
Cardiovascular · 119d
Cleared Dec 01, 2015
PCT System
K152211 · NKG
Centinel Spine, Inc.
Orthopedic · 116d
Cleared Dec 01, 2015
Adler MicroMed Laser Surgery Fibers
K152417 · GEX
Adler Micromed, Inc.
General & Plastic Surgery · 97d
Cleared Dec 01, 2015
NuVasive Foundation-LL System
K152943 · OVD
Nu Vasive, Incorporated
Orthopedic · 57d
Cleared Dec 01, 2015
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5...
K153148 · OZE
Centers For Disease Control and...
Microbiology · 32d
Cleared Nov 30, 2015
Vonflex S Putty
K152518 · ELW
Vericom Co., Ltd.
Dental · 88d
Cleared Nov 27, 2015
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove,...
K150238 · KGO
Medline Industries, Inc.
General Hospital · 298d
Cleared Nov 27, 2015
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
K150603 · BTR
Teleflexmedical, Inc.
Anesthesiology · 262d
Cleared Nov 27, 2015
Stay Fresh Hydrocolloid dressing
K151186 · FRO
Sarasota Medical Products, Inc.
General & Plastic Surgery · 207d
Cleared Nov 27, 2015
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
K151673 · JAK
Toshibamedical Systems Corporation
Radiology · 158d
Cleared Nov 27, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151679 · LYZ
Heze Yuze Glove Co., Ltd.
General Hospital · 158d
Cleared Nov 25, 2015
OT EQUATOR
K142211 · NHA
Rhein 83 Srl
Dental · 470d
Cleared Nov 25, 2015
SonicLift
K150077 · NFO
Pretika Corporation
Neurology · 315d
Cleared Nov 25, 2015
Cortisol Saliva Luminescence Immunoassay
K150528 · NHG
Ibl International GmbH
Chemistry · 268d