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
39721–39744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2013
INFLAMMA DRY
K132066 · PFQ
Rapid Pathogen Screening, Inc.
Chemistry · 141d
Cleared Nov 21, 2013
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
K132306 · OMB
Persyst Development Corp.
Neurology · 120d
Cleared Nov 20, 2013
HAMILTON-MR1
K122438 · CBK
Hamilton Medical AG
Anesthesiology · 467d
Cleared Nov 20, 2013
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
K130212 · FMI
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 295d
Cleared Nov 20, 2013
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
K130230 · FMF
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 295d
Cleared Nov 20, 2013
ISIRONA MAGELLAN
K130707 · MSX
Isirona, LLC
Cardiovascular · 250d
Cleared Nov 20, 2013
WRIGHT GRADIENT 52 - TORSO
K131387 · JOW
Wright Therapy Products, Inc.
Cardiovascular · 190d
Cleared Nov 20, 2013
MRI MARKER
K131689 · KXK
C4 Imaging, LLC
Radiology · 163d
Cleared Nov 20, 2013
BRONCHOSCOPY ELBOW
K132168 · BZD
Respironics, Inc.
Anesthesiology · 131d
Cleared Nov 20, 2013
MULTICAM 3000 ECO
K132347 · KPS
Inter Medical Medizintechnik GmbH
Radiology · 114d
Cleared Nov 20, 2013
AFFIX II SPINOUS PROCESS PLATE SYSTEM
K132411 · PEK
Nu Vasive, Incorporated
Orthopedic · 110d
Cleared Nov 20, 2013
APEX SPINE SYSTEM
K132603 · NKB
Spinecraft, LLC
Orthopedic · 92d
Cleared Nov 20, 2013
RETROARC RETROPUBIC SLING SYSTEM
K132655 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Nov 20, 2013
EVEREST SPINAL SYSTEM
K132757 · MNI
K2m, Inc.
Orthopedic · 77d
Cleared Nov 20, 2013
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · MWI
Welch Allyn, Inc.
Cardiovascular · 70d
Cleared Nov 20, 2013
AGAMATRIX HEALTH MANAGER
K132821 · NBW
Agamatrix, Inc.
Chemistry · 72d
Cleared Nov 20, 2013
I2C
K132847 · LHN
Ion Beam Applications S.A.
Radiology · 70d
Cleared Nov 20, 2013
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
K132893 · HWC
Icon Orthopaedic Concepts Dba Edge...
Orthopedic · 65d
Cleared Nov 20, 2013
MONACO
K132971 · MUJ
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Nov 20, 2013
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25...
K133008 · FCG
Beacon Endoscopic
Gastroenterology & Urology · 56d
Cleared Nov 20, 2013
NMI PICC III
K133264 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Nov 19, 2013
PARACE MD EKOSCOPE IS100
K123148 · DQD
Parace, LLC
Cardiovascular · 410d
Cleared Nov 19, 2013
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
K124006 · PFR
Illumina, Inc.
Pathology · 328d
Cleared Nov 19, 2013
SUMITOMO PROTON THERAPY SYSTEM
K130426 · LHN
Sumitomo Heavy Industries, Ltd.
Radiology · 272d