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
75313–75336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2002
PALMO THERMOREGULATION INTERFACE ACCESSORY
K014210 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 238d
Cleared Aug 16, 2002
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER
K021650 · GEX
Quantel Medical
General & Plastic Surgery · 88d
Cleared Aug 16, 2002
CEMENT RESTRICTOR, SMALL AND LARGE
K021765 · JDK
Exactech, Inc.
Orthopedic · 79d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960 · LFR
Abbott Laboratories
Chemistry · 63d
Cleared Aug 16, 2002
MULTI FUCTIONAL REHABILITATION CHAIR
K022407 · INO
Raye'S, Inc.
Physical Medicine · 23d
Cleared Aug 16, 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL...
K022463 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Aug 15, 2002
DB1 EMBRYO FREEZE
K011327 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 471d
Cleared Aug 15, 2002
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · JZG
The Binding Site, Ltd.
Immunology · 231d
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