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

Filters: Not cleared only ×
490 results
241–264 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Mar 28, 2019
LOADPRO™ Intraoperative Rod Strain Sensor
DEN180012 · QFP
Intellirod Spine, Inc.
Orthopedic · 379d
Not Cleared Mar 28, 2019
Leica FL400
DEN180024 · QFX
Leica Microsystems (Schweiz) AG
Neurology · 335d
Not Cleared Mar 14, 2019
ClearMate
DEN170044 · QFB
Thornhill Research, Inc.
Anesthesiology · 573d
Not Cleared Mar 12, 2019
Quantra Hemostasis Analyzer, QPlus Cartridge
DEN180017 · QFR
Hemosonics, LLC
Hematology · 344d
Not Cleared Mar 01, 2019
Early Bird Bleed Monitoring System
DEN180021 · QFJ
Saranas, Inc.
Cardiovascular · 312d
Not Cleared Feb 14, 2019
t:slim X2 insulin pump with interoperable technology
DEN180058 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 108d
Not Cleared Jan 23, 2019
Aptima Mycoplasma genitalium Assay
DEN180047 · QEP
Hologic, Inc.
Microbiology · 145d
Not Cleared Dec 28, 2018
EyeBOX
DEN170091 · QEA
Oculogica, Inc.
Neurology · 371d
Not Cleared Dec 21, 2018
MLL (KMT2A) Breakapart FISH Probe Kit
DEN170070 · QDI
Cytocell, Ltd.
Medical Genetics · 448d
Not Cleared Dec 21, 2018
Miris Human Milk Analyzer
DEN180007 · QEI
Miris AB
Chemistry · 312d
Not Cleared Dec 20, 2018
SEM Scanner (Model 200)
DEN170021 · QEF
Bruin Biometrics, LLC
Gastroenterology & Urology · 626d
Not Cleared Dec 20, 2018
Enlight 1810
DEN170072 · QEB
Timpel, Inc.
Anesthesiology · 447d
Not Cleared Dec 12, 2018
Retrograde Intubation Set
DEN170055 · QCX
Cook Incorporated
Anesthesiology · 443d
Not Cleared Nov 30, 2018
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
DEN180040 · QDZ
Meridian Bioscience, Inc.
Microbiology · 123d
Not Cleared Nov 19, 2018
QMS Plazomicin Immunoassay
DEN180030 · QDR
Microgenics Corporation
Toxicology · 147d
Not Cleared Nov 06, 2018
Innovo
DEN170049 · QAJ
Bio-Medical Research, Ltd.
Gastroenterology & Urology · 414d
Not Cleared Nov 02, 2018
Parathyroid Detection (Model PTeye) System
DEN170056 · QDF
Aibiomed, Corp.
General & Plastic Surgery · 403d
Not Cleared Nov 02, 2018
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
DEN170092 · QDG
Fluoptics
General & Plastic Surgery · 315d
Not Cleared Oct 31, 2018
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
DEN180028 · QDJ
23AndMe, Inc.
Chemistry · 148d
Not Cleared Oct 24, 2018
picoAMH ELISA
DEN180004 · QDH
Ansh Labs, LLC
Toxicology · 275d
Not Cleared Oct 05, 2018
Bose Hearing Aid
DEN180026 · QDD
Bose Corporation
Ear, Nose, Throat · 147d
Not Cleared Sep 28, 2018
Adaptive Biotechnologies clonoSEQ Assay
DEN170080 · QDC
Adaptive Biotechnologies Corporation
Pathology · 364d
Not Cleared Sep 21, 2018
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
DEN070001 · PBK
Centers For Disease Control and...
Microbiology · 4266d
Not Cleared Sep 11, 2018
Irregular Rhythm Notification Feature
DEN180042 · QDB
Apple, Inc.
Cardiovascular · 33d