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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
42601–42624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2012
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K122835 · LYZ
Yuanhang Plastic Co., Ltd.
General Hospital · 84d
Cleared Dec 10, 2012
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
K122874 · LZA
Nitrilist Gloves Manufacturing Sdn Bhd
General Hospital · 82d
Cleared Dec 07, 2012
SAFEAIR SMOKE PENCIL,
K120454 · GEI
Lna Medical Aps
General & Plastic Surgery · 297d
Cleared Dec 07, 2012
PC-60NW FINGERTIP OXIMETER
K120502 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 290d
Cleared Dec 07, 2012
BLOOD GLUCOSE MONITORING SYSTEM
K120813 · NBW
Andon Medical Co., Ltd.
Chemistry · 263d
Cleared Dec 07, 2012
OPELASER PRO II AND THE OPELASER LITE II
K120932 · GEX
The Yoshida Dental Mfg. Co., Ltd.
General & Plastic Surgery · 254d
Cleared Dec 07, 2012
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
K121495 · HRS
Aap Implantate AG
Orthopedic · 200d
Cleared Dec 07, 2012
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
K121703 · MUU
Medi-Khan USA, Inc.
General & Plastic Surgery · 182d
Cleared Dec 07, 2012
SMI CARDIOVASCULAR PATCH
K122105 · DXZ
Solinas Medical, Inc.
Cardiovascular · 143d
Cleared Dec 07, 2012
FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
K122330 · JOW
Arjohuntleigh Polska SP Z.O.O.
Cardiovascular · 127d
Cleared Dec 07, 2012
ZQUIET PRO-PLUS
K122475 · LRK
Sleeping Well, LLC
Dental · 115d
Cleared Dec 07, 2012
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY...
K122546 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 108d
Cleared Dec 07, 2012
DENTAL X-RAY Z70 (W)
K122582 · EHD
Denterprise International, Inc.
Radiology · 106d
Cleared Dec 07, 2012
REVERSE MEDICAL MICROCATHETER
K122684 · DQY
Reverse Medical Corporation
Cardiovascular · 98d
Cleared Dec 07, 2012
V2F ANTERIOR FIXATION SYSTEM
K122733 · KWQ
Zimmer Spine, Inc.
Orthopedic · 92d
Cleared Dec 07, 2012
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
K122742 · OLO
Nuvasive, Inc.
Orthopedic · 91d
Cleared Dec 07, 2012
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · DTM
Medtronic, Inc.
Cardiovascular · 88d
Cleared Dec 07, 2012
ES2 SPINAL SYSTEM MODEL 48280XXXX
K122845 · NKB
Stryker Spine
Orthopedic · 81d
Cleared Dec 07, 2012
XTOOL
K122861 · HRX
Ouroboros Medical
Orthopedic · 80d
Cleared Dec 07, 2012
OMNIPOD INSULIN MANAGMENT SYSTEM
K122953 · LZG
Insulet Corporation
General Hospital · 73d
Cleared Dec 07, 2012
DDRVERSA MOTION
K123005 · MQB
Swissray Medical AG
Radiology · 71d
Cleared Dec 07, 2012
VITESSE 3.0
K123152 · MUJ
Varian Medical Systems, Oncology Systems
Radiology · 59d
Cleared Dec 07, 2012
RMGI LOW VISCOSITY
K123265 · EMA
Pulpdent Corporation
Dental · 49d
Cleared Dec 07, 2012
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
K123273 · EMA
Temrex Corp.
Dental · 49d