FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73873–73896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
K022644 · NFK
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 06, 2002
BIRD AVEA VENTILATOR
K022674 · CBK
Bird Products Corp.
Anesthesiology · 86d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954 · DIO
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN THC TEST
K022955 · LDJ
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN OPIATES TEST
K023047 · DJG
Amedica Biotech, Inc.
Toxicology · 55d
Cleared Nov 06, 2002
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
K023344 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 30d
Cleared Nov 06, 2002
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
K023350 · CBK
Respironics California, Inc.
Anesthesiology · 30d
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d