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
56185–56208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2008
COMPREHENSIVE REVERSE SHOULDER
K080642 · PHX
Biomet, Inc.
Orthopedic · 125d
Cleared Jul 09, 2008
SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
K080689 · ILY
Premier Dynamics, Inc.
Physical Medicine · 120d
Cleared Jul 09, 2008
HUMIDAIRE 2I
K080797 · BTT
Resmed, Ltd.
Anesthesiology · 111d
Cleared Jul 09, 2008
BUSSE PLASTIC LOR SYRINGE
K080804 · CAZ
Busse Hosipital Disposables
Anesthesiology · 110d
Cleared Jul 09, 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260 · LZA
Kimberly-Clark Corp.
General Hospital · 68d
Cleared Jul 09, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K081329 · NLH
Ascent Healthcare Solutions
Cardiovascular · 58d
Cleared Jul 09, 2008
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
K081356 · HSB
Mylad Orthopedic Solutions, LLC
Orthopedic · 56d
Cleared Jul 09, 2008
NUWAV
K081781 · IYO
Laborie Medical Technologies, Corp.
Radiology · 15d
Cleared Jul 08, 2008
ACCIN BIPOLAR HEAD SYSTEM
K080647 · KWY
Accelerated Innovation, LLC
Orthopedic · 123d
Cleared Jul 08, 2008
BIRTHTRACK
K080672 · NPB
Barnev, Ltd.
Obstetrics & Gynecology · 120d
Cleared Jul 08, 2008
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
K081015 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Jul 07, 2008
MOSAIC ECO2 LASER SYSTEM
K080496 · GEX
Lutronic Corporation
General & Plastic Surgery · 136d
Cleared Jul 07, 2008
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043 · KOC
Nxstage Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · JIT
Siemens Healthcare Diagnostics
Chemistry · 20d
Cleared Jul 03, 2008
VASCON ROAMER MICROCATHETER
K053310 · KRA
Vascon, LLC
Cardiovascular · 948d
Cleared Jul 03, 2008
COMBI 8 MAX
K070888 · IPF
Cec Electronica S.R.L.
Physical Medicine · 461d
Cleared Jul 03, 2008
ACTIVE ANTERIOR CERVICAL PLATE SYSTEM
K073500 · KWQ
Sanacor
Orthopedic · 203d
Cleared Jul 03, 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR...
K073621 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 190d
Cleared Jul 03, 2008
COSTORSOL
K073693 · KDN
Preservation Solutions, Inc.
Gastroenterology & Urology · 185d
Cleared Jul 03, 2008
SYMMETRIC TOTAL KNEE SYSTEM
K080199 · JWH
Signal Medical Corporation
Orthopedic · 160d
Cleared Jul 03, 2008
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC),...
K080224 · DZE
SOADCO, S.L.
Dental · 156d
Cleared Jul 03, 2008
ONCOBIONIC BIPOLAR ELECTRODE
K080287 · GEI
AngioDynamics, Inc.
General & Plastic Surgery · 150d
Cleared Jul 03, 2008
UNIBLATE ELECTROSURGICAL DEVICE
K080451 · GEI
AngioDynamics, Inc.
General & Plastic Surgery · 135d
Cleared Jul 03, 2008
IDEAL LIFE POD (MODEL ILP 0001)
K080538 · NBW
Ideal Life, Inc.
Chemistry · 128d