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
57241–57264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2008
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
K070355 · GEX
Fotona D.D.
General & Plastic Surgery · 392d
Cleared Mar 04, 2008
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
K072793 · QPB
Moeller Medical GmbH & Co. KG
General & Plastic Surgery · 155d
Cleared Mar 04, 2008
QPLAQUE MR
K073156 · LNH
Medis Medical Imaging Systems BV
Radiology · 117d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · HWC
Smith & Nephew, Inc.
Orthopedic · 82d
Cleared Mar 04, 2008
FLEXOR EVAC ASPIRATION CATHETER
K073627 · QEZ
Cook, Inc.
Cardiovascular · 69d
Cleared Mar 04, 2008
BAXANO ULTRA LOW PROFILE RONGEUR
K080494 · HAE
Baxano, Inc.
Neurology · 11d
Cleared Mar 03, 2008
OMNILUX NEW-U
K072459 · OHS
Photo Therapeutics, Inc.
General & Plastic Surgery · 185d
Cleared Mar 03, 2008
NIOX MINO
K072816 · MXA
Aerocrine AB
Chemistry · 153d
Cleared Mar 03, 2008
CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
K073119 · NBW
Taidoc Technology Corporation
Chemistry · 119d
Cleared Mar 03, 2008
BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH...
K073339 · BRZ
Fenwal, Inc.
General Hospital · 96d
Cleared Mar 03, 2008
PLEXUR M
K073405 · MQV
Osteotech, Inc.
Orthopedic · 90d
Cleared Mar 03, 2008
VISTAKON (NARAFILCON) A SOFT CONTACT LENS
K073485 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 82d
Cleared Mar 03, 2008
MINITAPE EXTRA URETHRAL SLING
K073647 · OTN
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 68d
Cleared Mar 03, 2008
LED CURING LIGHT
K080035 · EBZ
Monitex Industrial Co., Ltd.
Dental · 56d
Cleared Feb 29, 2008
MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
K072274 · NBW
Bestgen Biotech Corp.
Chemistry · 198d
Cleared Feb 29, 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K072683 · JAD
Xoft, Inc.
Radiology · 161d
Cleared Feb 29, 2008
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
K072802 · LYY
Ultrawin Sdn Bhd
General Hospital · 151d
Cleared Feb 29, 2008
THE PROXIVENT KIT
K073061 · LBH
Coll Partners , Ltd.
Dental · 122d
Cleared Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
K073091 · NBC
bioMerieux, Inc.
Chemistry · 120d
Cleared Feb 29, 2008
ACCIN PATELLOFEMORAL SYSTEM
K073120 · KRR
Accelerated Innovation, LLC
Orthopedic · 116d
Cleared Feb 29, 2008
DC ULNAR SHORTENING SYSTEM
K073228 · HRS
Orthopro, LLC
Orthopedic · 106d
Cleared Feb 29, 2008
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL...
K073380 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 88d
Cleared Feb 29, 2008
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
K073402 · HSB
Synthes (Usa)
Orthopedic · 87d
Cleared Feb 29, 2008
SYNGO IMAGING CCF VA10A
K073418 · LLZ
Siemens AG Medical Solutions
Radiology · 86d