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
61849–61872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2006
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD
K061738 · JOJ
Albert Browne , Ltd.
General Hospital · 66d
Cleared Aug 25, 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
K061923 · JIX
Dade Behring, Inc.
Chemistry · 49d
Cleared Aug 25, 2006
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
K062036 · HCG
Micrus Endovascular Corporation
Neurology · 37d
Cleared Aug 25, 2006
PREMIER 11 HOLTER
K062088 · MLO
Diagnostic Monitoring Software
Cardiovascular · 32d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
K062121 · DKB
Dade Behring, Inc.
Chemistry · 31d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
K062122 · JIX
Dade Behring, Inc.
Chemistry · 31d
Cleared Aug 24, 2006
MONOBLOCK PRESS-FIT HIP STEM
K060072 · LPH
Omni Life Science, Inc.
Orthopedic · 227d
Cleared Aug 24, 2006
ABX PENTRA 400: LIPOPROTEINS
K060854 · JIT
Horiba Abx
Chemistry · 148d
Cleared Aug 24, 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · DZE
Straumann USA
Dental · 139d
Cleared Aug 24, 2006
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510,...
K061194 · MEG
Smiths Medical Asd, Inc.
General Hospital · 118d
Cleared Aug 24, 2006
ARROW PRESSURE INJECTABLE PICC
K061289 · LJS
Arrow International, Inc.
General Hospital · 107d
Cleared Aug 24, 2006
BODYGAURD PAIN MANAGER INFUSION SYSTEM
K061325 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 105d
Cleared Aug 24, 2006
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN...
K061551 · LYY
Medipure Corporation (M) Sdn. Bhd.
General Hospital · 80d
Cleared Aug 24, 2006
CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600
K061666 · GCJ
Mauna Kea Technologies
General & Plastic Surgery · 71d
Cleared Aug 24, 2006
AQUATINE EC ENDODONTIC CLEANSER
K061689 · KJJ
Puricore, Inc.
Dental · 70d
Cleared Aug 24, 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K061733 · DQO
AngioDynamics, Inc.
Cardiovascular · 65d
Cleared Aug 24, 2006
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K061845 · CFN
Dade Behring, Inc.
Immunology · 56d
Cleared Aug 24, 2006
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
K062137 · HGM
Philips Medizin Systeme Boeblingen GmbH
Radiology · 29d
Cleared Aug 24, 2006
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL
K062140 · OCL
Cryocath Technologies, Inc.
Cardiovascular · 28d
Cleared Aug 24, 2006
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
K062169 · HET
Applied Medical Resources Corp.
Obstetrics & Gynecology · 24d
Cleared Aug 24, 2006
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
K062293 · LRG
Dade Behring, Inc.
Microbiology · 17d
Cleared Aug 24, 2006
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
K062381 · DTZ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 9d
Cleared Aug 23, 2006
ONLINE TDM PROCAINAMIDE
K060773 · LAR
Roche Diagnostics Corp.
Toxicology · 154d
Cleared Aug 23, 2006
ENDOSCOPIC SPINE SYSTEM
K061246 · HRX
Arthro Kinetics, Inc.
Orthopedic · 112d