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

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176,076 results
74929–74952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2002
INJEX NEEDLE-FREE INJECTION SYSTEM
K020786 · KZE
Rosch AG Medizintechnic
General Hospital · 198d
Cleared Sep 25, 2002
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER)
K020879 · FZP
Integrated Vascular Systems, Inc.
General & Plastic Surgery · 191d
Cleared Sep 25, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 98d
Cleared Sep 25, 2002
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 &...
K022100 · HAW
Image-Guided Neurologics, Inc.
Neurology · 89d
Cleared Sep 25, 2002
ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES...
K022659 · LYY
Purna Bina Sdn Bhd
General Hospital · 47d
Cleared Sep 25, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 47d
Cleared Sep 25, 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL &...
K022889 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 26d
Cleared Sep 25, 2002
BARDPORT X-PORT ISP PORT
K022983 · LJT
C.R. Bard, Inc.
General Hospital · 16d
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
CARDIS
K023015 · DQK
Schwarzer GmbH
Cardiovascular · 15d
Cleared Sep 24, 2002
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K020280 · BZG
Morgan Medical , Ltd.
Anesthesiology · 239d
Cleared Sep 24, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
K020712 · GZJ
Biomedical Life Systems, Inc.
Neurology · 203d
Cleared Sep 24, 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
K021152 · NAY
Computer Motion, Inc.
General & Plastic Surgery · 167d
Cleared Sep 24, 2002
ICASE
K021248 · LRX
Ikeeps, Inc.
Ophthalmic · 158d
Cleared Sep 24, 2002
FIRST CHOICE & FIRST CHOICE PLUS
K022076 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Sep 24, 2002
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · DXO
Radi Medical Systems AB
Cardiovascular · 81d
Cleared Sep 24, 2002
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
K022344 · KWQ
Centerpulse Spine-Tech, Inc.
Orthopedic · 67d
Cleared Sep 24, 2002
CADENCE SPINAL FIXATION SYSTEM
K022374 · KWP
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Sep 24, 2002
LUNEAU 3 MIRROR LENS
K022413 · HJK
Luneau SA
Ophthalmic · 62d
Cleared Sep 24, 2002
LIFEGUARD
K022755 · KHE
Medtek, LLC
Hematology · 35d
Cleared Sep 24, 2002
NELLCOR N-200 PULSE OXIMETER, MODEL N-200
K022819 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 29d
Cleared Sep 24, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · CHH
Polymer Technology Systems, Inc.
Chemistry · 21d