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
70681–70704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 240d
Cleared Dec 04, 2003
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · HKX
Nidek, Inc.
Ophthalmic · 183d
Cleared Dec 04, 2003
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
K032309 · LRX
Novelens, Inc.
Ophthalmic · 132d
Cleared Dec 04, 2003
UP-GRADE FOREHEAD THERMOMETER
K032362 · FLL
Medisim, Ltd.
General Hospital · 126d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · KXA
DePuy Orthopaedics, Inc.
Orthopedic · 98d
Cleared Dec 04, 2003
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
K032756 · EIA
A-Dec, Inc.
Dental · 90d
Cleared Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED...
K032900 · DSY
Edwards Lifesciences, LLC
Cardiovascular · 78d
Cleared Dec 04, 2003
MIRAGE ACTIVA MASK
K032916 · BZD
Resmed, Ltd.
Anesthesiology · 73d
Cleared Dec 04, 2003
VISION-TECH YZ SLIT LAMP, MODEL 66
K033190 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 64d
Cleared Dec 04, 2003
SENO ADVANTAGE
K033400 · LLZ
Ge Medical Systems W-400
Radiology · 41d
Cleared Dec 04, 2003
LAMITRODE SPINAL CORD STIMULATION LEADS
K033429 · GZB
Advanced Neuromodulation Systems
Neurology · 37d
Cleared Dec 04, 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE,...
K033576 · FPA
Abbott Laboratories
General Hospital · 21d
Cleared Dec 04, 2003
BOBCAT PRO SCALER SYSTEM, MODEL G-130
K033705 · ELC
Dentsply International
Dental · 9d
Cleared Dec 03, 2003
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
K024027 · ILY
Skytech Enterprises, Inc.
Physical Medicine · 362d
Cleared Dec 03, 2003
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K030485 · MQN
Newmedical Technology, Inc.
Dental · 292d
Cleared Dec 03, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · GEX
Candela Corp.
General & Plastic Surgery · 261d
Cleared Dec 03, 2003
ASEPTICO ENDOPEX V, MODEL AEU-40
K030895 · LQY
Aseptico, Inc.
Dental · 257d
Cleared Dec 03, 2003
VECTRA (INTELECT) EPR ULTRASOUND
K031116 · IMI
Chattanooga Group
Physical Medicine · 239d
Cleared Dec 03, 2003
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
K031818 · MQX
Facilai Enterprises , Ltd.
General Hospital · 174d
Cleared Dec 03, 2003
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · EBW
A-Dec, Inc.
Dental · 105d
Cleared Dec 03, 2003
PERMAQUICK SE BONDING SYSTEM
K032626 · KLE
Ultradent Products, Inc.
Dental · 99d
Cleared Dec 03, 2003
Z-SERIES MODULAR TOTAL HIP SYSTEM
K032729 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 91d
Cleared Dec 03, 2003
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
K032735 · GEX
Max Engineering , Ltd.
General & Plastic Surgery · 90d
Cleared Dec 03, 2003
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
K032752 · KWQ
R&B Surgical Solutions, LLC
Orthopedic · 89d