FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74593–74616 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2002
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
K022569 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 27d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · JHY
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 28, 2002
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · FRG
Advanced Sterilization Products
General Hospital · 356d
Cleared Aug 28, 2002
SR IVOCRON
K013869 · EBG
Ivoclar Vivadent, Inc.
Dental · 280d
Cleared Aug 28, 2002
RADIOSYSTEM/NT, MODEL 80-13020
K020320 · IYE
Styker Instruments
Radiology · 209d
Cleared Aug 28, 2002
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
K020550 · DSI
Datascope Corp.
Cardiovascular · 190d
Cleared Aug 28, 2002
INTROCAN SAFETY IV CATHETER
K020785 · FOZ
B.Braun Medical, Inc.
General Hospital · 170d
Cleared Aug 28, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K021804 · GEI
Medtronic Vascular
General & Plastic Surgery · 86d
Cleared Aug 28, 2002
SUTURE FIXATION DEVICE
K021834 · GAW
Mle, Inc.
General & Plastic Surgery · 85d
Cleared Aug 28, 2002
POLY-CARB
K022030 · EBG
Inovativ, LLC
Dental · 68d
Cleared Aug 28, 2002
RF TENT
K022157 · LNH
Odin Medical Technologies , Ltd.
Radiology · 57d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
Cleared Aug 28, 2002
HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS
K022334 · MQL
Intl., Inc.
Obstetrics & Gynecology · 41d
Cleared Aug 28, 2002
HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
K022352 · MQL
Intl., Inc.
Obstetrics & Gynecology · 40d
Cleared Aug 28, 2002
SPERMASSIST
K022443 · MQL
Nidacon International AB
Obstetrics & Gynecology · 34d
Cleared Aug 28, 2002
ACIDIFIED TYRODES SOLUTION
K022547 · MQL
Intl., Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 28, 2002
VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
K022718 · GEI
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 13d
Cleared Aug 28, 2002
7F LAUNCHER GUIDE CATHETER
K022764 · DQY
Medtronic Vascular
Cardiovascular · 7d
Cleared Aug 28, 2002
THE AUTOTAC SYSTEM TITANIUM TACK
K022790 · DZL
BioHorizons Implant Systems, Inc.
Dental · 6d
Cleared Aug 27, 2002
3A DENTAL IMPLANT SYSTEM
K011879 · DZE
Osseco Biosource, Ltd.
Dental · 438d
Cleared Aug 27, 2002
PALMLIGHT
K020057 · EBZ
CAO Group, Inc.
Dental · 231d
Cleared Aug 27, 2002
APL IGA ELISA KIT
K021398 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 117d
Cleared Aug 27, 2002
14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55
K021759 · MSD
Medcomp
Gastroenterology & Urology · 90d