FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74401–74424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2002
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL...
K021442 · BTM
Oemedic International, Inc.
Anesthesiology · 85d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482 · NIY
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Jul 30, 2002
CHROLOY
K021969 · EJH
Neirynck & Vogt NV
Dental · 43d
Cleared Jul 30, 2002
QUINCKE SPINAL NEEDLE
K022029 · BSP
Epimed International, Inc.
Anesthesiology · 39d
Cleared Jul 30, 2002
PROVOX FREEHANDS HME, MODEL 7710
K022125 · EWL
Atos Medical AB
Ear, Nose, Throat · 29d
Cleared Jul 30, 2002
VERDICT-II
K022141 · DJC
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Jul 30, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K022296 · GEI
Neothermia Corp.
General & Plastic Surgery · 14d
Cleared Jul 30, 2002
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC...
K022303 · IYN
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Jul 30, 2002
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
K022355 · DIO
Branan Medical Corp.
Toxicology · 11d
Cleared Jul 29, 2002
REPROCESSED TROCARS AND CANNULAS
K012644 · NLM
Surgical Instruments Service and...
Gastroenterology & Urology · 350d
Cleared Jul 29, 2002
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K013263 · LKP
Fred Hutchinson Cancer Research Center
Immunology · 301d
Cleared Jul 29, 2002
WISORB MALLEOLAR SCREW
K020222 · HWC
Cambridge Scientific, Inc.
Orthopedic · 188d
Cleared Jul 29, 2002
READI-STRAND
K020337 · KXK
Worldwide Medical Technologies, LLC
Radiology · 178d
Cleared Jul 29, 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · HCG
MicroVention, Inc.
Neurology · 171d
Cleared Jul 29, 2002
ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
K020657 · NHN
Acculaser, Inc.
Physical Medicine · 151d
Cleared Jul 29, 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · DCK
Hemagen Diagnostics, Inc.
Chemistry · 105d
Cleared Jul 29, 2002
RESORBABLE CRANIAL CLAMPS
K021408 · GXR
Synthes (Usa)
Neurology · 87d
Cleared Jul 29, 2002
HERPESELECT 1 ELISA IGG, MODEL EL0910G
K021429 · MXJ
Focus Technologies, Inc.
Microbiology · 87d
Cleared Jul 29, 2002
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K021604 · HBL
Ohio Medical Instrument Co., Inc.
Neurology · 74d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653 · JXG
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757 · DCN
Good Biotech Corp.
Immunology · 61d
Cleared Jul 29, 2002
ADVANTAGE SIM 6.0
K021780 · KPQ
General Electric Medical Systems
Radiology · 60d
Cleared Jul 29, 2002
ADMIRA SEAL
K021842 · EBC
Voco GmbH
Dental · 54d
Cleared Jul 29, 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · MNH
Endius, Inc.
Orthopedic · 52d