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

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175,820 results
40129–40152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2013
AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
K132554 · HRS
Aap Implantate AG
Orthopedic · 50d
Cleared Oct 03, 2013
PASS LP SPINAL SYSTEM
K132575 · OSH
Medicrea International
Orthopedic · 48d
Cleared Oct 03, 2013
LOCKING PLATE SYSTEM
K132642 · HRS
Beijing Libeier Bio-Engineering...
Orthopedic · 38d
Cleared Oct 03, 2013
EMBOZENE MICROSPHERES
K132675 · KRD
Celonova Biosciences, Inc.
Cardiovascular · 36d
Cleared Oct 03, 2013
NAUTILUS SPINAL SYSTEM
K132760 · NKB
Life Spine, Inc.
Orthopedic · 29d
Cleared Oct 03, 2013
PICCOLO COMPOSITE NAILING SYSTEM
K132774 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 28d
Cleared Oct 02, 2013
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON...
K131975 · CFJ
Alfa Wassermann Diagnostic...
Chemistry · 96d
Cleared Oct 02, 2013
FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K132600 · JEY
Biomet Microfixation
Dental · 43d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693 · PSZ
Becton, Dickinson and Company
Microbiology · 34d
Cleared Oct 01, 2013
PATIENT MONITOR
K123711 · MWI
Shenzhen Creative Industry Co., Ltd.
Cardiovascular · 301d
Cleared Oct 01, 2013
ACCESS TOTAL BHCG (5TH IS)
K130020 · DHA
Beckman Coulter, Inc.
Chemistry · 271d
Cleared Oct 01, 2013
TRINITY ELE
K131251 · NFO
Carol Cole Company
Neurology · 153d
Cleared Oct 01, 2013
MPACT DM LINER CONVERTER
K131458 · LZO
Medacta International
Orthopedic · 134d
Cleared Sep 30, 2013
TYBER MEDICAL INTERBODY SYSTEM
K130573 · ODP
Tyber Medical, LLC
Orthopedic · 210d
Cleared Sep 30, 2013
WIRED MOUTH PROTECTOR (WMP)
K131396 · PFL
Elba Laboratories, Inc.
Dental · 138d
Cleared Sep 30, 2013
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS,...
K131845 · KWI
Acumed, LLC
Orthopedic · 101d
Cleared Sep 30, 2013
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION...
K132044 · GXR
Neos Surgery S.L
Neurology · 90d
Cleared Sep 30, 2013
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
K132097 · JAQ
Best Medical International, Inc.
Radiology · 84d
Cleared Sep 30, 2013
SHASER HRS2 RX HAIR REMOVAL SYSTEM
K132266 · ONF
Shaser, Inc.
General & Plastic Surgery · 70d
Cleared Sep 27, 2013
THEYFIT MALE CONDOM
K122219 · HIS
Theyfit
Obstetrics & Gynecology · 429d
Cleared Sep 27, 2013
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
K123822 · FRN
Hk Surgical, Inc.
General Hospital · 289d
Cleared Sep 27, 2013
MASTERTORQUE LUX 8900 L
K130560 · EFB
Kaltenbach & Voigt GmbH
Dental · 207d
Cleared Sep 27, 2013
BESTFIT2 NASAL MASK
K130663 · BZD
Curative Medical, Inc.
Anesthesiology · 199d
Cleared Sep 27, 2013
STRYKER NAV3I PLATFORM
K130874 · HAW
Stryker Corporate
Neurology · 182d