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

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176,076 results
55057–55080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2008
AVALON ELITE VASCULAR ACCESS KIT
K081940 · DRE
Avalon Laboratories, LLC
Cardiovascular · 133d
Cleared Nov 18, 2008
SYNTHEMED DEVICE
K082276 · LYA
Synthemed, Inc.
Ear, Nose, Throat · 99d
Cleared Nov 18, 2008
DIGITAL RADIOGRAPHY, FLEXDR C30
K082347 · MQB
Konica Minolta Technoproduct Co., Ltd.
Radiology · 95d
Cleared Nov 18, 2008
FIBERNET EMBOLIC PROTECTION SYSTEM
K082348 · NTE
Lumen Biomedical, Inc.
Cardiovascular · 95d
Cleared Nov 18, 2008
STEREO NAVIGATOR ACCESSORY, STN-1000
K082354 · KPS
Naviscan Pet Systems
Radiology · 95d
Cleared Nov 18, 2008
DEPUY SIGMA CR-F FEMORAL COMPONENT
K082500 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 81d
Cleared Nov 18, 2008
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650 · KTT
Synthes (Usa)
Orthopedic · 67d
Cleared Nov 18, 2008
IC-PRO SYSTEM, VERSION 3.1.0.4
K082907 · IZI
Paieon, Inc.
Radiology · 49d
Cleared Nov 18, 2008
VIDA PULMONARY WORKSTATION 2 (PW2)
K083227 · JAK
Vida Diagnostics, Inc.
Radiology · 15d
Cleared Nov 17, 2008
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
K080623 · CHH
Jas Diagnostics, Inc.
Chemistry · 257d
Cleared Nov 17, 2008
SRI LP DRAPE
K080796 · KKX
Sri/Surgical Express
General Hospital · 242d
Cleared Nov 17, 2008
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · JFJ
Medica Corp.
Chemistry · 238d
Cleared Nov 17, 2008
LANG DENTAL ACRYLIC PRIMER
K081981 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 129d
Cleared Nov 17, 2008
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
K082568 · GEI
Bovie Medical
General & Plastic Surgery · 74d
Cleared Nov 14, 2008
SPECTRAL OCT/SLO
K080460 · OBO
Opko Health, Inc.
Ophthalmic · 268d
Cleared Nov 14, 2008
TANDA SKINCARE SYSTEM, MODEL: PTSCS
K080591 · GEX
Pharos Life Corporation
General & Plastic Surgery · 256d
Cleared Nov 14, 2008
NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS
K081123 · FPA
Nexus Medical, LLC
General Hospital · 207d
Cleared Nov 14, 2008
TENACORE OXYGEN BLENDER, MODEL TB-2000
K081335 · BZR
Tenacore Holdings, Inc.
Anesthesiology · 186d
Cleared Nov 14, 2008
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
K081673 · MAX
Ionics Medical Corp.
Orthopedic · 154d
Cleared Nov 14, 2008
CUFFALERT
K081805 · BSK
Sunmed
Anesthesiology · 141d
Cleared Nov 14, 2008
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K081906 · KWP
Globus Medical, Inc.
Orthopedic · 134d
Cleared Nov 14, 2008
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · DRC
Oscor, Inc.
Cardiovascular · 123d
Cleared Nov 14, 2008
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · LXB
Oticon Medical AB
Ear, Nose, Throat · 112d
Cleared Nov 14, 2008
DEPUY SPINE LATERAL CAGE SYSTEM
K082128 · MAX
Depuy Spine
Orthopedic · 108d