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
43657–43680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO...
K121987 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 26d
Cleared Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · MOB
Inova Diagnostics, Inc.
Immunology · 334d
Cleared Jul 31, 2012
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · DAP
bioMerieux, Inc.
Hematology · 307d
Cleared Jul 31, 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · OKS
Quest Medical, Inc.
Ophthalmic · 284d
Cleared Jul 31, 2012
HQS INTRODUCER
K113849 · DYB
Alseal
Cardiovascular · 215d
Cleared Jul 31, 2012
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
K120283 · EMA
Novocol, Inc.
Dental · 182d
Cleared Jul 31, 2012
OSSEOSPEED PLUS
K120414 · DZE
Astra Tech AB
Dental · 172d
Cleared Jul 31, 2012
VICTUS LASER PLATFORM
K120426 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 169d
Cleared Jul 31, 2012
SYNTHES MATRIX SYSTEM
K120838 · NKB
Synthes Spine
Orthopedic · 133d
Cleared Jul 31, 2012
DIAZYME HOMOCYSTEINE POC TEST KIT
K121053 · LPS
Diazyme Laboratories
Chemistry · 116d
Cleared Jul 31, 2012
ATOM 1 (MODEL: BRC 2200)
K121578 · GZJ
Bioelectric Research Corporation
Neurology · 62d
Cleared Jul 30, 2012
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
K113199 · OMP
Kevo Medical Supplies
General & Plastic Surgery · 273d
Cleared Jul 30, 2012
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
K120467 · NKB
Spinal Elements, Inc.
Orthopedic · 166d
Cleared Jul 30, 2012
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
K120511 · NFO
Leto Enterprise , Ltd.
Neurology · 160d
Cleared Jul 30, 2012
SENTINEL
K120668 · IYE
C-Rad Positioning AB
Radiology · 147d
Cleared Jul 30, 2012
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
K121231 · NGT
Ind Ndiagnostic, Inc.
General Hospital · 97d
Cleared Jul 30, 2012
DYNAPBV BODY SOFTWARE
K121292 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jul 30, 2012
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
K121299 · NKB
Safe Orthopaedics
Orthopedic · 91d
Cleared Jul 30, 2012
XPRESSWAY RX CATHETER (6F LD-VERISON)
K121301 · QEZ
Kaneka Pharma America, LLC
Cardiovascular · 90d
Cleared Jul 30, 2012
HIP SYSTEMS
K121308 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jul 30, 2012
DYNASTY BIOFOAM SHELL
K121544 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Jul 30, 2012
PLATO MICROCATH 27 MICROCATHETER
K121734 · DQO
Scientia Vascular, LLC
Cardiovascular · 47d
Cleared Jul 27, 2012
MULTIPLATE 5.0 AGGREGOMETER
K103555 · JOZ
Verum Diagnostica GmbH
Hematology · 602d
Cleared Jul 27, 2012
HC-BIOS DENTAL IMPLANT
K110425 · DZE
Hung Chun Bio-S Co., Ltd.
Dental · 529d