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
69625–69648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2004
BIOCRYL RAPIDE INTERFERENCE SCREW
K032717 · HWC
Mitek Worldwide
Orthopedic · 211d
Cleared Mar 31, 2004
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K033074 · NPK
Inion , Ltd.
Dental · 184d
Cleared Mar 31, 2004
OTOFLEX 100 TYE 1012
K033645 · ETY
Gn Otometrics A/S
Ear, Nose, Throat · 132d
Cleared Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702 · MQP
Blackstone Medical, Inc.
Orthopedic · 127d
Cleared Mar 31, 2004
MERLIN SPINE SYSTEM
K033901 · NKB
Depuy Spine, Inc.
Orthopedic · 105d
Cleared Mar 31, 2004
CORLINK AUTOMATED ANASTOMOTIC SYSTEM
K033979 · FZP
By-Pass Makafim , Ltd.
General & Plastic Surgery · 99d
Cleared Mar 31, 2004
AESCULAP ABSORBABLE CRANIOFIX
K040080 · GXR
Aesculap, Inc.
Neurology · 76d
Cleared Mar 31, 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · MQN
Synthes (Usa)
Dental · 76d
Cleared Mar 31, 2004
ONEUSE- PLUS MICROKERATOME
K040297 · HMY
Moria SA
Ophthalmic · 51d
Cleared Mar 31, 2004
MANUAL WHEELCHAIR SERIES
K040561 · IOR
Shanghai Wheelchair Factory
Physical Medicine · 28d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · MNI
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · HWC
United States Surgical, A Division of...
Orthopedic · 23d
Cleared Mar 31, 2004
ULTRASOUND IMAGING SYSTEM, MODEL 7300
K040596 · IYN
Esaote, S.P.A.
Radiology · 23d
Cleared Mar 30, 2004
LIQUID OXYGEN SYSTEM
K032143 · BYJ
Micro Technology Services, Inc.
Anesthesiology · 260d
Cleared Mar 30, 2004
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
K034011 · GEX
Laserscope
General & Plastic Surgery · 97d
Cleared Mar 30, 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · FGE
Boston Scientific
Gastroenterology & Urology · 82d
Cleared Mar 30, 2004
CARRARA INTERACTION CERAMIC SYSTEM
K040635 · EIH
Dentsply Intl.
Dental · 20d
Cleared Mar 29, 2004
DUREX FLAVORED LATEX CONDOM
K032227 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 252d
Cleared Mar 29, 2004
THE ULTRA SYSTEM
K032445 · KCT
Promedica, Inc.
General Hospital · 234d
Cleared Mar 29, 2004
MLT-1000 IR LASER SYSTEM
K033986 · ILY
Medical Laser Therapeutics LP
Physical Medicine · 97d
Cleared Mar 29, 2004
PROFILE 2000/3000 LASER SYSTEM
K040005 · GEX
Sciton, Inc
General & Plastic Surgery · 87d
Cleared Mar 29, 2004
NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040040 · LLZ
Barco NV Barcoview
Radiology · 80d
Cleared Mar 29, 2004
NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040041 · LLZ
Barco NV Barcoview
Radiology · 80d
Cleared Mar 29, 2004
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
K040065 · JOW
Jack Speer and Assoc., Inc.
Cardiovascular · 76d