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
57529–57552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2008
SOLCART B
K072760 · KPO
B. Braun Medizintechnologie GmbH
Gastroenterology & Urology · 123d
Cleared Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
K073092 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 89d
Cleared Jan 29, 2008
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
K073135 · LXT
Synthes (Usa)
Orthopedic · 83d
Cleared Jan 29, 2008
MAXCEM 2
K073209 · MZW
Kerr Corporation
Dental · 76d
Cleared Jan 29, 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · KWQ
Nuvasive, Inc.
Orthopedic · 69d
Cleared Jan 29, 2008
VALEO PEDICLE SCREW SPINAL SYSTEM
K073430 · NKB
Amedica Corp.
Orthopedic · 54d
Cleared Jan 29, 2008
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
K073676 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 32d
Cleared Jan 29, 2008
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE
K073719 · GCJ
Advanced Surgical Concepts
General & Plastic Surgery · 29d
Cleared Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jan 28, 2008
IMPULSE 6000D/7000DP
K072114 · DRL
Fluke Biomedical
Cardiovascular · 180d
Cleared Jan 28, 2008
BUTREX BUTTRESS PLATING SYSTEM
K072943 · KWQ
X-Spine Systems, Inc.
Orthopedic · 103d
Cleared Jan 28, 2008
QUANTA LITE F-ACTIN IGA ELISA
K072967 · MVM
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Jan 28, 2008
AXIS SYSTEM
K072989 · EFB
Dentsply Intl., Inc.
Dental · 97d
Cleared Jan 28, 2008
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
K073233 · HSH
Advanced Bio-Surfaces, Inc.
Orthopedic · 74d
Cleared Jan 28, 2008
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 33d
Cleared Jan 28, 2008
DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
K073701 · ITI
Dane Technologies
Physical Medicine · 28d
Cleared Jan 28, 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026 · MNI
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Jan 28, 2008
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K080075 · MNI
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 17d
Cleared Jan 25, 2008
WATERLASE MD DERM
K071734 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 213d
Cleared Jan 25, 2008
INSUCOZI INSULIN VIAL COVER
K072174 · IQG
41 Industries, LLC
General Hospital · 172d
Cleared Jan 25, 2008
BIOSET XCH
K072238 · MQV
Regeneration Technologies, Inc.
Orthopedic · 165d
Cleared Jan 25, 2008
STALIF (TM) C
K072415 · OVE
Surgicraft , Ltd.
Orthopedic · 150d
Cleared Jan 25, 2008
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
K072607 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 130d
Cleared Jan 25, 2008
GLYCERIN & PARABEN FREE ASTROGLIDE
K072647 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 128d