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
62113–62136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 2006
NEWPORT E500 WAVE VENTILATOR
K061094 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 100d
Cleared Jul 28, 2006
PRIMA ANAESTHESIA MACHINE
K061102 · BSZ
Penlon , Ltd.
Anesthesiology · 100d
Cleared Jul 28, 2006
BIOLUCENT APPLICATOR, MODEL RTA-XX
K061241 · JAQ
Biolucent, Inc.
Radiology · 86d
Cleared Jul 28, 2006
DIAGNOSOFT HARP
K061368 · LNH
Diagnosoft, Inc.
Radiology · 73d
Cleared Jul 28, 2006
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE...
K061561 · KGI
Hologic, Inc.
Radiology · 53d
Cleared Jul 28, 2006
ECLIPSE WAX REMOVER
K061580 · EBI
Dentsply International
Dental · 51d
Cleared Jul 28, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP)...
K061673 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jul 28, 2006
MRGFUS GENERAL PURPOSE AND BREAST COIL
K061715 · MOS
Insightec Txsonics, Inc.
Radiology · 39d
Cleared Jul 28, 2006
ACTIVE RENIN IRMA
K061758 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 36d
Cleared Jul 28, 2006
STA - CONTROL LA 1+2
K061803 · GGC
Diagnostica Stago, Inc.
Hematology · 31d
Cleared Jul 28, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K061913 · LHN
Ion Beam Applications S.A.
Radiology · 22d
Cleared Jul 28, 2006
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
K061930 · LNH
Fonar Corp.
Radiology · 21d
Cleared Jul 28, 2006
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND...
K061952 · MOS
Invivo
Radiology · 18d
Cleared Jul 28, 2006
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE,...
K062024 · LFM
Dade Behring, Inc.
Toxicology · 10d
Cleared Jul 27, 2006
IMPLANTIUM PROSTHETICS
K052957 · NHA
Dentium Co., Ltd.
Dental · 279d
Cleared Jul 27, 2006
TOPSLANE DMLC
K060187 · IXI
Topslane International, LLC
Radiology · 184d
Cleared Jul 27, 2006
KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
K061180 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 91d
Cleared Jul 27, 2006
MASIMO SET RADICAL 7 PULSE CO-OXIMETER
K061204 · DQA
Masimo Corporation
Anesthesiology · 87d
Cleared Jul 27, 2006
URGOTUL AG
K061220 · FRO
Laboratoires Urgo
General & Plastic Surgery · 87d
Cleared Jul 27, 2006
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
K061423 · KWA
Biomet Manufacturing Corp
Orthopedic · 65d
Cleared Jul 27, 2006
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
K061621 · HWC
Synthes (Usa)
Orthopedic · 45d
Cleared Jul 27, 2006
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640 · GWM
Integra LifeSciences Corporation
Neurology · 45d
Cleared Jul 27, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
K061643 · IYN
Shimadzu Medical Systems
Radiology · 45d
Cleared Jul 27, 2006
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
K061854 · NKB
Stryker Spine
Orthopedic · 27d