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
58225–58248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2007
TEXTRONICS ECG ELECTRODE
K071576 · DRX
Textronics, Inc.
Cardiovascular · 147d
Cleared Nov 02, 2007
SCHICK COMPUTED ORAL RADIOLOGY SYSTEM
K072134 · MUH
Schick Technologies, Inc.
Radiology · 92d
Cleared Nov 02, 2007
AMPLATZER TORQVUE DELIVERY SYSTEM
K072313 · DQY
Aga Medical Corp.
Cardiovascular · 77d
Cleared Nov 02, 2007
TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M
K072532 · LLZ
Dooyang Systems, Inc.
Radiology · 56d
Cleared Nov 02, 2007
BLOODSTOP HEMOSTATIC GAUZE
K072681 · QSY
Lifescience Plus, Inc.
General & Plastic Surgery · 42d
Cleared Nov 02, 2007
ACTIVASCREW
K072848 · HWC
Bioretec, Ltd.
Orthopedic · 29d
Cleared Nov 02, 2007
VENDYS, MODEL 6000 B B/C
K072919 · DQK
Endothelix, Inc.
Cardiovascular · 18d
Cleared Nov 01, 2007
IOL INJECTOR SET
K070669 · KYB
Medicel AG
Ophthalmic · 234d
Cleared Nov 01, 2007
MODULARIS VARIOSTAR
K070799 · LNS
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 223d
Cleared Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 209d
Cleared Nov 01, 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Nov 01, 2007
WIM-PC, MODEL 1010
K071955 · BZM
Karmelsonix
Anesthesiology · 108d
Cleared Nov 01, 2007
GRIPPER MICRO NEEDLE
K072059 · FMI
Smiths Medical MD, Inc.
General Hospital · 98d
Cleared Nov 01, 2007
TITANIUM POWERPORT ISP IMPLANTED PORT
K072215 · LJT
C.R. Bard, Inc.
General Hospital · 84d
Cleared Nov 01, 2007
SPINEFRONTIER DORADO VBR
K072289 · MAX
Spinefrontier, Inc.
Orthopedic · 77d
Cleared Nov 01, 2007
MEGA SPINE SYSTEM
K072436 · MNI
Bk Meditech, Co., Ltd.
Orthopedic · 63d
Cleared Nov 01, 2007
DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
K072641 · FLL
Famidoc Technology Co., Ltd.
General Hospital · 44d
Cleared Nov 01, 2007
CSNP-001A NEURO PACKAGE
K072693 · JAK
Toshiba America Medical Systems, In.C
Radiology · 38d
Cleared Nov 01, 2007
IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
K072998 · LNH
Ge Medical Systems, LLC
Radiology · 8d
Cleared Oct 31, 2007
GALTSTICK INTRODUCER SYSTEM
K071330 · DRE
Galt Medical Corp.
Cardiovascular · 173d
Cleared Oct 31, 2007
Z-800 VOLUMETRIC INFUSION PUMP
K071545 · FRN
Zyno Medical, LLC
General Hospital · 147d
Cleared Oct 31, 2007
CYTOPLAST PTFE SUTURE
K072076 · NBY
Osteogenics Biomedical, Inc.
General & Plastic Surgery · 93d
Cleared Oct 31, 2007
PTFE PEEL AWAY MICROINTRODUCER
K072130 · DYB
Intromed
Cardiovascular · 90d
Cleared Oct 31, 2007
BIOPLEX VASCULITIS KIT
K072358 · MVJ
Bio-Rad Laboratories
Immunology · 70d