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

Filters: Cleared only ×
176,076 results
75193–75216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2002
HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
K021916 · FPA
Harmac Medical Products, Inc.
General Hospital · 79d
Cleared Aug 29, 2002
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
K021988 · FRN
Medrad, Inc.
General Hospital · 72d
Cleared Aug 29, 2002
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K022031 · BSZ
Draeger Medical, Inc.
Anesthesiology · 69d
Cleared Aug 29, 2002
ACETAL
K022032 · EHP
Inovativ, LLC
Dental · 69d
Cleared Aug 29, 2002
SAFEPRO SAFETY SYRINGE
K022063 · MEG
Formosa Medical Devices, Inc.
General Hospital · 65d
Cleared Aug 29, 2002
JENSEN GOLD FOIL
K022206 · EJT
Jensen Industries, Inc.
Dental · 55d
Cleared Aug 29, 2002
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
K022260 · LGM
Isolation Systems, Inc.
General Hospital · 62d
Cleared Aug 29, 2002
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
K022568 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 27d
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