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
63145–63168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2006
IN-OVATION C
K060837 · NJM
Dentsply International
Dental · 13d
Cleared Apr 07, 2006
RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1
K051227 · JOW
Renu Medical, Inc.
Cardiovascular · 330d
Cleared Apr 07, 2006
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
K051798 · DZE
Osteomed LP
Dental · 276d
Cleared Apr 07, 2006
HUMAPEN MEMOIR
K053563 · FMF
Eli Lilly and Company
General Hospital · 107d
Cleared Apr 07, 2006
LIGHTSHEER DUET LASER SYSTEM
K053628 · GEX
Lumenis, Inc.
General & Plastic Surgery · 99d
Cleared Apr 07, 2006
VPAP III ST-A/KIDSTA MASK SYSTEM
K060105 · MNS
Resmed, Ltd.
Anesthesiology · 84d
Cleared Apr 07, 2006
VECTRA LASER SYSTEM
K060114 · GEX
Xintec Corporation, Dba,
General & Plastic Surgery · 80d
Cleared Apr 07, 2006
HARMONIC SCALPEL BLADES AND SHEARS
K060245 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared Apr 07, 2006
HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K060315 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 58d
Cleared Apr 07, 2006
SEE-IT CARIES DETECTOR
K060330 · LFC
Ronvig Dental Mfg. A/S
Dental · 57d
Cleared Apr 07, 2006
THE AMO OPHTHALMIC SURGICAL SYSTEM
K060366 · HQC
Advanced Medical Optics, Inc.
Ophthalmic · 53d
Cleared Apr 07, 2006
AESCULAP CRANIOFACIAL PLATE AND SCREW
K060492 · JEY
Aesculap, Inc.
Dental · 42d
Cleared Apr 07, 2006
VALPLAST YAMAHACHI TEETH
K060507 · ELM
Valplast Intl. Corp.
Dental · 39d
Cleared Apr 07, 2006
GELPORT BLUNT TIP TROCAR SYSTEM
K060629 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 29d
Cleared Apr 07, 2006
MACTRODE 3
K060661 · DRX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared Apr 07, 2006
NAKED
K060797 · HIS
Veraxis Int'L, Inc.
Obstetrics & Gynecology · 14d
Cleared Apr 07, 2006
SEEKER/SPARK ULTRASOUND SYSTEM
K060800 · IYO
Ardent Sound, Inc.
Radiology · 14d
Cleared Apr 07, 2006
VISUM LED SURGICAL LIGHTING SYSTEM
K060802 · FSY
Stryker Communications Corp.
General & Plastic Surgery · 14d
Cleared Apr 07, 2006
SVIEW
K060840 · LLZ
Mri Cardiac Services, Incorporated
Radiology · 10d
Cleared Apr 06, 2006
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K050988 · DLG
Lin-Zhi International, Inc.
Toxicology · 352d
Cleared Apr 06, 2006
AWQ-104
K050989 · GZJ
Lhasa Oms, Inc.
Neurology · 352d
Cleared Apr 06, 2006
TECHLAB ASCA-CHEK
K051927 · NBT
Techlab, Inc.
Immunology · 262d
Cleared Apr 06, 2006
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
K052420 · HIB
Gynova, LLC
Obstetrics & Gynecology · 216d
Cleared Apr 06, 2006
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413 · FMF
Terumo Europe N.V.
General Hospital · 120d