FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142945–142968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1986
ULTRAHESIVE II POSTOP ELECTRODE
K862028 · GXY
Medical Devices, Inc.
Neurology · 65d
Cleared Aug 01, 1986
STANDARD BASIN KIT CUSTOM BASIN KIT
K862241 · FRG
Quali-Med, Inc.
General Hospital · 50d
Cleared Aug 01, 1986
DART AMYLASE-D.S. REAGENT SYSTEM
K862370 · CIJ
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Aug 01, 1986
PDQ AMEBIASIS
K862473 · KHW
Diamedix Corp.
Microbiology · 32d
Cleared Aug 01, 1986
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
K862513 · JXG
Cordis Corp.
Neurology · 31d
Cleared Aug 01, 1986
MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS
K862523 · EKW
Walter Lorenz Surgical, Inc.
Dental · 30d
Cleared Aug 01, 1986
MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE
K862533 · JEY
Walter Lorenz Surgical, Inc.
Dental · 30d
Cleared Aug 01, 1986
ULTRATHERM 808 I
K862589 · IMJ
Elmed, Inc.
Physical Medicine · 25d
Cleared Aug 01, 1986
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K862604 · CBK
Puritan Bennett Corp.
Anesthesiology · 24d
Cleared Aug 01, 1986
I22 INITIALES
K862621 · ERA
Oticon Corp.
Ear, Nose, Throat · 22d
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