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
74713–74736 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2002
TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
K020537 · DXN
Tensys Medical, Inc.
Cardiovascular · 177d
Cleared Aug 15, 2002
INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
K021718 · MUH
Suni Imaging Microsystems, Inc.
Radiology · 84d
Cleared Aug 15, 2002
FORTITUDE CEMENT RESTRICTOR
K021719 · JDK
Spinal Concepts, Inc.
Orthopedic · 84d
Cleared Aug 15, 2002
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
K021747 · GCI
Surgicon, Inc.
General & Plastic Surgery · 79d
Cleared Aug 15, 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 79d
Cleared Aug 15, 2002
KSEA QUADRO SWITCH
K021776 · OCX
Karl Storz Endoscopy
Gastroenterology & Urology · 78d
Cleared Aug 15, 2002
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · LDJ
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Aug 15, 2002
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
K022025 · EJK
Milton Hodosh, M.D.
Dental · 56d
Cleared Aug 15, 2002
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
K022045 · LON
bioMerieux, Inc.
Microbiology · 52d
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