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
50137–50160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2010
DARCO HEADED CANNULATED SCREW
K100359 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared Jun 24, 2010
CONSENSUS REVISION KNEE SYSTEM
K100542 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 119d
Cleared Jun 24, 2010
MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
K100665 · FMF
Needle Tech Products, Inc.
General Hospital · 108d
Cleared Jun 24, 2010
AEDIS(TM)
K100902 · DZE
Embed Technology, LLC
Dental · 84d
Cleared Jun 24, 2010
VASOVAPOR
K101320 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 44d
Cleared Jun 24, 2010
BD DIRECTIGEN EX FLU A+B
K101461 · PSZ
Becton, Dickinson and Company
Microbiology · 29d
Cleared Jun 23, 2010
B-GENIN AND R-GENIN
K091912 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 363d
Cleared Jun 23, 2010
MAM TWISTER
K092781 · KKO
Mam International AG
Dental · 286d
Cleared Jun 23, 2010
CEDARA WEBACCESS, MODEL: 2.4
K092915 · LLZ
Cedara Software Corp.
Radiology · 274d
Cleared Jun 23, 2010
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
K093078 · HWC
Bonutti Research, Inc.
Orthopedic · 266d
Cleared Jun 23, 2010
CORONIS FUSION 10MP, MODEL MDCG-10130
K093197 · LLZ
Barco N.V.
Radiology · 257d
Cleared Jun 23, 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · KWP
Nuvasive, Inc.
Orthopedic · 243d
Cleared Jun 23, 2010
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820
K093707 · HSB
U&I Corp.
Orthopedic · 203d
Cleared Jun 23, 2010
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
K100403 · DQA
Masimo Corporation
Anesthesiology · 127d
Cleared Jun 23, 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM
K100409 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 127d
Cleared Jun 23, 2010
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
K100438 · NKB
Ebi, L.P.
Orthopedic · 126d
Cleared Jun 23, 2010
ACL TIGHTROPE
K100652 · HTY
Arthrex, Inc.
Orthopedic · 107d
Cleared Jun 23, 2010
KAI SPOT MODEL KMS 200
K100773 · BZQ
Kai Medical, Inc.
Anesthesiology · 97d
Cleared Jun 23, 2010
MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT...
K100798 · FRN
Medrad, Inc.
Radiology · 93d
Cleared Jun 23, 2010
SLEEVE WITH ZIPLOOP FIXATION DEVICES
K101063 · MBI
Biomet Sports Medicine
Orthopedic · 68d
Cleared Jun 23, 2010
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING,...
K101116 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 63d
Cleared Jun 23, 2010
MAC-MOBILE AQUATIC CHAIR
K101217 · IOR
Rehamed Intl., LLC
Physical Medicine · 54d
Cleared Jun 23, 2010
BACK-TEK
K101227 · ILY
York Biomedical, Inc.
Physical Medicine · 51d
Cleared Jun 23, 2010
MIRADA XD
K101228 · LLZ
Mirada Medical, Ltd.
Radiology · 51d