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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143545–143568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1986
I22 CITE
K862622 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
I81 CITE
K862624 · ERA
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
SONORANGER TRANSVAGINAL PROBE
K862627 · HEM
Ausonics Pty , Ltd.
Obstetrics & Gynecology · 22d
Cleared Aug 01, 1986
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · BTR
Mallinckrodt Critical Care
Anesthesiology · 18d
Cleared Aug 01, 1986
MECHANICAL CYSTITOME
K862709 · HNY
Rudolph Beaver, Inc.
Ophthalmic · 16d
Cleared Aug 01, 1986
SACCOMANNO SPECIMAN SOLUTION
K862725 · LDZ
Mill-Rose Laboratory
Pathology · 15d
Cleared Aug 01, 1986
DISPOSABLE SHOE COVERS AND NURSES CAPS
K862726 · FXP
Abco Dealers, Inc.
General Hospital · 14d
Cleared Aug 01, 1986
STA-SOF BREAST COMPRESSOR-CLAMP
K862731
Sta-Sof, Inc.
General & Plastic Surgery · 14d
Cleared Aug 01, 1986
CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND
K862734 · IYB
D&R X-Ray Products, Inc.
Radiology · 11d
Cleared Aug 01, 1986
CUSTOM IN-THE-EAR AND CANAL HEARING AID
K862754 · ESD
Cochlear Laboratories, Ltd.
Ear, Nose, Throat · 10d
Cleared Aug 01, 1986
MP-XMM DISPOSABLE FACE MASK
K862781 · BSJ
Medipart Jerry Alexander
Anesthesiology · 9d
Cleared Aug 01, 1986
MP-XML DISPOSABLE FACE MASK
K862782 · BSJ
Medipart Jerry Alexander
Anesthesiology · 9d
Cleared Aug 01, 1986
MP-XMV DISPOSABLE FACE MASK
K862783 · BSJ
Medipart Jerry Alexander
Anesthesiology · 9d
Cleared Aug 01, 1986
MP-XMO DISPOSABLE FACE MASK
K862784 · BSJ
Medipart Jerry Alexander
Anesthesiology · 9d
Cleared Aug 01, 1986
MP-1204 DISPOSABLE BACTERIA FILTER
K862785 · CAH
Medipart Jerry Alexander
General Hospital · 9d
Cleared Aug 01, 1986
MP-50T DISPOSABLE BREATHING CIRCUIT FILTER
K862786 · CAH
Medipart Jerry Alexander
General Hospital · 9d
Cleared Aug 01, 1986
MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER
K862787 · CAH
Medipart Jerry Alexander
General Hospital · 9d
Cleared Aug 01, 1986
MP-4400 MOUTHPIECE-FLANGE SEAL
K862788 · BYP
Medipart Jerry Alexander
Anesthesiology · 9d
Cleared Aug 01, 1986
MP-01X DISPOSABLE BACTERIA FILTER KIT
K862789 · CAH
Medipart Jerry Alexander
General Hospital · 9d
Cleared Aug 01, 1986
MP-01X-I DISPOSABLE FILTER KIT
K862790 · CAH
Medipart Jerry Alexander
General Hospital · 9d
Cleared Aug 01, 1986
MP-30XM-IE FACE MASK AND FILTER KIT
K862791 · IYT
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-066 RADIOAEROSOL KIT
K862792 · IYT
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-066-M RADIOAEROSOL KIT
K862793 · IYT
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-070 RADIOAEROSOL KIT
K862794 · IYT
Medipart Jerry Alexander
Radiology · 9d