FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69337–69360 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 03, 2003
ELPHA 4 CONTI
K032988 · KPI
Danmeter A/S
Gastroenterology & Urology · 70d
Cleared Dec 03, 2003
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
K033082 · FLL
Metatech Co., Ltd.
General Hospital · 65d
Cleared Dec 03, 2003
ADVANTAGE PADDLE
K033202 · IZH
Livingston Products, Inc.
Radiology · 62d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Dec 03, 2003
MODIFICATION TO TELEGRAPH HUMERAL NAIL
K033510 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 27d
Cleared Dec 03, 2003
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Dec 03, 2003
TIE-IN TRAPEZIUM
K033529 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Dec 03, 2003
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · KTT
Ebi, L.P.
Orthopedic · 14d