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
72073–72096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2003
MODEL J-5 MVO-MONITOR
K031998 · NUW
Myotronics-Noromed, Inc.
Dental · 27d
Cleared Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
K032013 · GKZ
Beckman Coulter, Inc.
Hematology · 24d
Cleared Jul 24, 2003
KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60
K032081 · EIH
Kavo America
Dental · 17d
Cleared Jul 24, 2003
WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A
K032174 · LLZ
Wide Corporation
Radiology · 8d
Cleared Jul 23, 2003
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS,...
K014074 · BZD
Hoffrichter GmbH
Anesthesiology · 590d
Cleared Jul 23, 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044 · DQA
Nonin Medical, Inc.
Anesthesiology · 314d
Cleared Jul 23, 2003
PICOSAT II SPO2 PULSE OXIMETRY MODULE
K030973 · DQA
Philips Medical Systems
Anesthesiology · 117d
Cleared Jul 23, 2003
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 &...
K031173 · GDF
Needle Tech Products, Inc.
General & Plastic Surgery · 100d
Cleared Jul 23, 2003
SCANLUBE
K031222 · MUI
Sonotech, Inc.
Radiology · 97d
Cleared Jul 23, 2003
XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
K031256 · FDA
Olympus Opto-Electronics Co., Ltd.
Gastroenterology & Urology · 93d
Cleared Jul 23, 2003
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
K031390 · LGZ
Minimed, Inc.
General Hospital · 82d
Cleared Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
K031459 · DQY
Guidant Corp.
Cardiovascular · 76d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · DIO
Dade Behring, Inc.
Toxicology · 70d
Cleared Jul 23, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
K031575 · JJY
Cliniqa Corporation
Immunology · 64d
Cleared Jul 23, 2003
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
K031920 · ITX
Trans Vascular Incorporated
Radiology · 30d
Cleared Jul 22, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K030637 · QEY
Ekos Corp.
Cardiovascular · 144d
Cleared Jul 22, 2003
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161 · DRF
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared Jul 22, 2003
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K031355 · NKB
Ebi, L.P.
Orthopedic · 84d
Cleared Jul 22, 2003
EBI SPINELINK SPINAL FIXATION SYSTEM
K031424 · NKB
Ebi, L.P.
Orthopedic · 77d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · DSH
Philips Medical Systems
Cardiovascular · 14d
Cleared Jul 21, 2003
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
K024377 · QJQ
Kalaco Scientific, Inc.
Neurology · 202d
Cleared Jul 21, 2003
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
K030033 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 199d
Cleared Jul 21, 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · GAR
Sri Orion Pharmaceuticals & Sutures
General & Plastic Surgery · 185d
Cleared Jul 21, 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · HCG
Micro Therapeutics, Inc.
Neurology · 166d