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: Cleared only ×
176,076 results
54793–54816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2008
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
K083527 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 20d
Cleared Dec 17, 2008
MIS CREST WIDENER
K080458 · MQN
Mis - Implant Technologies , Ltd.
Dental · 301d
Cleared Dec 17, 2008
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT...
K080794 · LPL
Polyvue Distribution, Inc.
Ophthalmic · 272d
Cleared Dec 17, 2008
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165 · MNH
Spineart
Orthopedic · 237d
Cleared Dec 17, 2008
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K081412 · FRN
Hospira, Inc.
General Hospital · 211d
Cleared Dec 17, 2008
TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
K081498 · DXN
Biocomfort Diagnostics GmbH & Co. KG
Cardiovascular · 202d
Cleared Dec 17, 2008
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
K081715 · NBW
Taidoc Technology Corporation
Chemistry · 182d
Cleared Dec 17, 2008
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
K081788 · FLL
Innochips Technology Co., Ltd.
General Hospital · 176d
Cleared Dec 17, 2008
REPROCESSED ENT SHAVERS
K081814 · ERL
Sterilmed, Inc.
Ear, Nose, Throat · 174d
Cleared Dec 17, 2008
INVISALIGN SYSTEM
K081960 · NXC
Align Technology
Dental · 161d
Cleared Dec 17, 2008
BARD PTFE (TEFLON) COATED GUIDE WIRES
K082094 · DQX
C.R. Bard Inc., Bard...
Cardiovascular · 146d
Cleared Dec 17, 2008
HEMOSTASYL PASTE
K082116 · MVL
Satelec
Dental · 142d
Cleared Dec 17, 2008
PERMA FIBER,MODEL 441
K082180 · EBI
Angelus Industria DE Productos...
Dental · 138d
Cleared Dec 17, 2008
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
K082344 · DWF
Sorin Group Deutschland GmbH
Cardiovascular · 124d
Cleared Dec 17, 2008
HEARTSUITE HEMODYNAMICS 7.10
K082421 · DQK
Emageon, Inc.
Cardiovascular · 117d
Cleared Dec 17, 2008
FLOWPICC CATHETER
K082481 · LJS
Vasonova, Inc.
General Hospital · 111d
Cleared Dec 17, 2008
SYMPHONY METER REMOTE
K082590 · LZG
Lifescan, Inc.
General Hospital · 100d
Cleared Dec 17, 2008
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
K082625 · HRS
Synthes (Usa)
Orthopedic · 99d
Cleared Dec 17, 2008
THROMBO TEK PSE, MODEL 90-480
K082631 · GGP
R2 Diagnostics, Inc.
Hematology · 98d
Cleared Dec 17, 2008
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
K082725 · GBX
Maquet Cardiovascular, LLC
General & Plastic Surgery · 91d
Cleared Dec 17, 2008
ML24000 UVA-1 PHOTOTHERAPY CABINET
K082731 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 90d
Cleared Dec 17, 2008
MODIFICATION TO MINISPIR, SPIROLAB III
K082766 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 86d
Cleared Dec 17, 2008
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
K082783 · MRZ
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Dec 17, 2008
STASYS MOTION CORRECTION SOFTWARE
K082904 · KPS
Digirad Corp.
Radiology · 78d