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
36529–36552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2014
VASCU-GUARD Peripheral Vascular Patch
K142461 · DXZ
Synovis Life Technologies, Inc.
Cardiovascular · 84d
Cleared Nov 25, 2014
Univers Rivers Shoulder Prosthesis System
K142863 · PHX
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 25, 2014
Sherpa Pak Kidney Transport System
K143054 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 25, 2014
Sherpa Pak Cardiac Transport System
K143074 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 24, 2014
HUMICARE D900
K133766 · BTT
Gruendler GmbH
Anesthesiology · 348d
Cleared Nov 24, 2014
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
K140566 · JOJ
Crosstex International
General Hospital · 264d
Cleared Nov 24, 2014
WOUNDCLOT HEMOSTATIC GAUZE
K140573 · QSY
Core Scientific , Ltd.
General & Plastic Surgery · 263d
Cleared Nov 24, 2014
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
K140716 · MAX
Interventional Spine, Inc.
Orthopedic · 248d
Cleared Nov 24, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K141682 · OGZ
Infraredx, Inc.
Cardiovascular · 154d
Cleared Nov 24, 2014
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT
K141939 · BTR
Teleflexmedical, Inc.
Anesthesiology · 130d
Cleared Nov 24, 2014
CONCHASMART COLUMN
K141940 · BTT
Teleflex, Inc.
Anesthesiology · 130d
Cleared Nov 24, 2014
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH...
K141952 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 129d
Cleared Nov 24, 2014
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K142072 · KWS
Custom Orthopaedic Solutions, Inc.
Orthopedic · 124d
Cleared CT Nov 24, 2014
SIGNA PET/MR
K142098 · OUO
Ge Medical Systems, LLC
Radiology · 115d
Cleared CT Nov 24, 2014
EEVA SYSTEM
K142147 · PBH
Auxogyn, Inc.
Obstetrics & Gynecology · 111d
Cleared Nov 24, 2014
MAYFIELD Skull Clamp
K142238 · HBL
Integra LifeSciences Corporation
Neurology · 103d
Cleared Nov 24, 2014
KangLi pedical screw spinal system
K142290 · MNH
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 98d
Cleared Nov 24, 2014
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical...
K142403 · KWS
Zimmer GmbH
Orthopedic · 89d
Cleared Nov 24, 2014
IntelAir Nasal Airway Support System
K142467 · CCK
Abeon Medical Corporation
Anesthesiology · 82d
Cleared Nov 24, 2014
Collagen Dental Membrane - Conformable IIBP
K142496 · NPL
Collagen Matrix, Inc.
Dental · 80d
Cleared Nov 24, 2014
Atlas SPEEDER Head/Neck
K142802 · MOS
Quality Electrodynamics, LLC
Radiology · 56d
Cleared Nov 22, 2014
XPERT FLU/RSV XC ASSAY
K142045 · OCC
Cepheid
Microbiology · 117d
Cleared Nov 21, 2014
STIM PROBE
K133348 · ETN
Spes Medica Srl
Ear, Nose, Throat · 387d
Cleared Nov 21, 2014
SGS DENTAL IMPLANT
K133362 · DZE
Sgs International, Ltd.
Dental · 385d