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
74473–74496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2002
SPERM CRYOPROTEC
K023206 · MQL
Nidacon International AB
Obstetrics & Gynecology · 44d
Cleared Nov 08, 2002
PRIMAGARD SURGICAL GOWNS
K023266 · FYA
Primeline Medical Products, Inc.
General Hospital · 39d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 08, 2002
MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
K023413 · GEI
Neothermia Corp.
General & Plastic Surgery · 28d
Cleared Nov 08, 2002
MODIFICATION TO VKS KNEE SYSTEM
K023416 · JWH
Plus Orthopedics
Orthopedic · 28d
Cleared Nov 08, 2002
MODIFICATION TO GELBFISH VASCULAR DILATORS
K023507 · DRE
Vascumetrix, LLC
Cardiovascular · 21d
Cleared Nov 08, 2002
ECAT LSO PET/CT 16
K023518 · KPS
Cti Pet Systems, Inc.
Radiology · 18d
Cleared Nov 08, 2002
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
K023590 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 14d
Cleared Nov 08, 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K023596 · MOS
Medrad, Inc.
Radiology · 11d
Cleared Nov 07, 2002
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER
K014218 · DQA
Dolphin Medical, Inc.
Anesthesiology · 321d
Cleared Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · DRX
Bio Protech, Inc.
Cardiovascular · 309d
Cleared Nov 07, 2002
FUNDUS AUTOIMAGER
K020888 · HKI
Visual Pathways, Inc.
Ophthalmic · 234d
Cleared Nov 07, 2002
ARTHREX FIBERWIRE IN USP SIZES
K021434 · GAT
Arthrex, Inc.
General & Plastic Surgery · 185d
Cleared Nov 07, 2002
PISTON SYRINGE & HYPODERMIC NEEDLE
K022159 · FMF
International Medsurg Connection
General Hospital · 128d
Cleared Nov 07, 2002
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
K022655 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 90d
Cleared Nov 07, 2002
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
K022675 · EBF
Prime Dental Manufacturing, Inc.
Dental · 87d
Cleared Nov 07, 2002
BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
K023039 · BRZ
Tuta Healthcare Pty Limited
General Hospital · 56d
Cleared Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · JXM
Beckman Coulter, Inc.
Toxicology · 55d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417 · JDR
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Nov 07, 2002
TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
K023458 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 23d
Cleared Nov 07, 2002
CENTRICITY PACS PLUS
K023557 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Nov 07, 2002
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
K023631 · NHA
Astra Tech, Inc.
Dental · 9d
Cleared Nov 06, 2002
CO-AXIAL INTRODUCER NEEDLE
K022634 · DYB
Promex, Inc.
Cardiovascular · 90d