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
69409–69432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2004
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
K020700 · BTT
Pegasus Research Corp.
Anesthesiology · 784d
Cleared Apr 26, 2004
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
K022256 · FXX
Tucker & Associates
General Hospital · 654d
Cleared Apr 26, 2004
SERVO GUARD, MODEL 64 81 290 EH88E
K030071 · CAH
Maquet, Inc.
General Hospital · 474d
Cleared Apr 26, 2004
KETOCHECKS
K033114 · JIN
Neo Diagnostics, Inc.
Chemistry · 209d
Cleared Apr 26, 2004
NARKOMED 6400, MODEL NM6400
K033498 · BSZ
Draeger Medical, Inc.
Anesthesiology · 173d
Cleared Apr 26, 2004
MULTIBLAST MEDIUM
K034063 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 117d
Cleared Apr 26, 2004
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME...
K040287 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 80d
Cleared Apr 26, 2004
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX...
K040605 · BZQ
Dymedix, Inc.
Anesthesiology · 49d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 25d
Cleared Apr 23, 2004
5M MEDICAL FLAT PANEL DISPLAY, ME511L
K031661 · LLZ
Totoku Electric Co., Ltd.
Radiology · 331d
Cleared Apr 23, 2004
DICOM THEATER
K033153 · LLZ
Ferguson Medical
Radiology · 206d
Cleared Apr 23, 2004
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
K033860 · JIT
Wako Chemicals USA, Inc.
Chemistry · 133d
Cleared Apr 23, 2004
COMPUMEDICS SUMMIT IP
K040194 · MNR
Compumedics USA, Ltd.
Anesthesiology · 86d
Cleared Apr 23, 2004
CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
K040468 · LLZ
Cedara Software Corp.
Radiology · 59d
Cleared Apr 23, 2004
CRYO 5
K040727 · GEX
Zimmer Elektromedizin GmbH
General & Plastic Surgery · 32d
Cleared Apr 23, 2004
MODIFICATION TO OUTBACK CATHETER
K040771 · DQY
Lumend, Inc.
Cardiovascular · 29d
Cleared Apr 23, 2004
LIFEPAK 12
K040775 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 28d
Cleared Apr 23, 2004
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K040821 · FZP
Coalescent Surgical
General & Plastic Surgery · 24d
Cleared Apr 23, 2004
PREVIEW TREATMENT PLANNING SOFTWARE
K040852 · LLZ
Medical Media Systems, Inc.
Radiology · 22d
Cleared Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · IZH
Hologic, Inc.
Radiology · 18d
Cleared Apr 23, 2004
TEM 3000 HEAD COIL
K040937 · MOS
Mr Instruments, Inc.
Radiology · 11d
Cleared Apr 22, 2004
PRODOSE AAD SYSTEM
K030747 · CAF
Profile Therapeutics Plc
Anesthesiology · 409d
Cleared Apr 22, 2004
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
K032981 · BSP
Invamed Technologies, Inc.
Anesthesiology · 211d
Cleared Apr 22, 2004
VITALSENSE
K033534 · FLL
Mini-Mitter Co., Inc.
General Hospital · 164d