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
64273–64296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
K051161 · DKZ
Quest Diagnostics, Inc.
Toxicology · 201d
Cleared Nov 22, 2005
WIESLAB CAP PR-3 ANCA
K051458 · MOB
Eurodiagnostica
Immunology · 173d
Cleared Nov 22, 2005
IUI CATHETER, MODEL 9057
K052059 · MQF
Inntec, Inc.
Obstetrics & Gynecology · 116d
Cleared Nov 22, 2005
RPS ADENO DETECTOR
K052092 · GOD
Rapid Pathogen Screening
Microbiology · 112d
Cleared Nov 22, 2005
VILEX X-FIX
K052196 · KTT
Vilex, Inc.
Orthopedic · 103d
Cleared Nov 22, 2005
RAPID PROGEAMMER 3.0
K052374 · GZB
Advanced Neuromodulation Systems
Neurology · 84d
Cleared Nov 22, 2005
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · DWF
Medtronic Perfusion Systems
Cardiovascular · 69d
Cleared Nov 22, 2005
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND...
K052612 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 61d
Cleared Nov 22, 2005
DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
K052784 · DXN
Welch Allyn, Inc.
Cardiovascular · 50d
Cleared Nov 22, 2005
SOPRANO HAIR REMOVAL DIODE LASER
K052874 · GEX
Msq (M2) , Ltd.
General & Plastic Surgery · 41d
Cleared Nov 22, 2005
NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
K052879 · JWH
Zimmer, Inc.
Orthopedic · 41d
Cleared Nov 22, 2005
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977 · DQK
Ge Healthcare
Cardiovascular · 29d
Cleared Nov 22, 2005
DEPUY CMW 1 GENTAMICIN BONE CEMENT
K053002 · MBB
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Nov 22, 2005
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
K053003 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Nov 22, 2005
VISTADENT AT COMPLETE, MODEL 3.1
K053010 · LLZ
Dentsply Intl., Inc.
Radiology · 27d
Cleared Nov 22, 2005
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · MWI
Welch Allyn, Inc.
Cardiovascular · 26d
Cleared Nov 22, 2005
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
K053038 · KTT
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Nov 21, 2005
SKELITE RESORBABLE CEMENT RESTRICTOR
K051836 · JDK
Millenium Biologix, Inc.
Orthopedic · 138d
Cleared Nov 21, 2005
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
K052099 · LYA
Polyganics B.V.,
Ear, Nose, Throat · 110d
Cleared Nov 21, 2005
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
K052381 · DTL
Zerusa Limited
Cardiovascular · 83d
Cleared Nov 21, 2005
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
K052702 · GEI
Misonix, Inc.
General & Plastic Surgery · 54d
Cleared Nov 21, 2005
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
K052837 · KGO
Terang Nusa Sdn Bhd
General Hospital · 46d
Cleared Nov 21, 2005
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
K053000 · CAC
Haemonetics Corp.
Anesthesiology · 27d
Cleared Nov 21, 2005
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · HBL
Integra LifeSciences Corporation
Neurology · 24d