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
74209–74232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2002
BLADDERSCAN BVI 6100
K022153 · IYO
Diagnostic Ultrasound Corp.
Radiology · 44d
Cleared Aug 15, 2002
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · JHO
Helena Laboratories
Chemistry · 28d
Cleared Aug 15, 2002
AUTOPULSE RESUSCITATION SYSTEM
K022345 · DRM
Revivant Corp.
Cardiovascular · 27d
Cleared Aug 15, 2002
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
K022347 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 27d
Cleared Aug 15, 2002
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL...
K022348 · CAC
Interpore Cross Intl.
Anesthesiology · 27d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS,...
K022525 · JJS
Bio-Rad
Immunology · 15d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS...
K022529 · JJS
Bio-Rad
Chemistry · 15d
Cleared Aug 15, 2002
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K022548 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 14d
Cleared Aug 15, 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586 · JWH
Biomet Orthopedics, Inc.
Orthopedic · 10d
Cleared Aug 14, 2002
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · NLH
Sterilmed, Inc.
Cardiovascular · 373d
Cleared Aug 14, 2002
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012678 · NLH
Sterilmed, Inc.
Cardiovascular · 365d
Cleared Aug 14, 2002
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
K013038 · DTZ
Polystan A/S
Cardiovascular · 338d
Cleared Aug 14, 2002
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K013618 · MQN
Osteomed Corp.
Dental · 282d
Cleared Aug 14, 2002
DASH 3000/4000 PATIENT MONITOR
K020290 · MHX
General Electric Medical Systems...
Cardiovascular · 198d
Cleared Aug 14, 2002
SERRALGUT
K020597 · GAL
Serral, S.A. DE C.V.
General & Plastic Surgery · 173d
Cleared Aug 14, 2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710 · GKR
Biotest Medizintechnik GmbH
Hematology · 162d
Cleared Aug 14, 2002
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
K020984 · MKJ
Access Cardiosystems, Inc.
Cardiovascular · 149d
Cleared Aug 14, 2002
ECAT VISION PET SCANNER, MODELS 3000 & 5000
K021633 · KPS
Cti Pet Systems, Inc.
Radiology · 89d
Cleared Aug 14, 2002
SYNTHES CRANIOFACIAL PLATES
K021642 · JEY
Synthes (Usa)
Dental · 86d
Cleared Aug 14, 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER,...
K021707 · KNW
Senorx, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 14, 2002
BILAYER MATRIX WOUND DRESSING
K021792 · KGN
Integra Lifesciences Corp.
General & Plastic Surgery · 75d
Cleared Aug 14, 2002
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
K021808 · FZP
Weck
General & Plastic Surgery · 72d
Cleared Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898 · FGE
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Aug 14, 2002
MAEDA SILVER ACUPUNCTURE NEEDLE
K021904 · MQX
Maeda Toyokichi Shoten
General Hospital · 65d