FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
123937–123960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1990
MODIFIED CASS SYSTEM
K902488 · KXK
Medical Instrumentation & Diagnostics...
Radiology · 191d
Cleared Dec 07, 1990
LDL-DIRECT CONTROLS
K902740 · JJY
Isolab, Inc.
Chemistry · 168d
Cleared Dec 07, 1990
BRACKET, METAL, ORTHODOTNIC
K902809 · EJF
Masel Industries, Inc.
Dental · 163d
Cleared Dec 07, 1990
ENDOSCOPIC LIGHT SOURCE 250 ENDO
K903790 · FCW
Orlux Engineering and Instrumentation
Gastroenterology & Urology · 109d
Cleared Dec 07, 1990
SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM
K904203 · GEX
Surgilase, Inc.
General & Plastic Surgery · 86d
Cleared Dec 07, 1990
PAROJECT ANESTHETIC SYRINGE
K904279 · EGM
Ronvig Instruments, Ltd.
Dental · 81d
Cleared Dec 07, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K904330 · DHB
Ventrex Laboratories, Inc.
Immunology · 78d
Cleared Dec 07, 1990
KLEARTEX LATEX SURGEONS GLOVES
K904361 · KGO
Kleartex Sdn Bhd
General Hospital · 74d
Cleared Dec 07, 1990
BATTERY-POWERED TOOTHBRUSH
K904401 · JEQ
The B & F System, Inc.
Dental · 73d
Cleared Dec 07, 1990
NIDEK INC. MODEL AC-2000 DERM
K904402 · GEX
Nidek, Inc.
General & Plastic Surgery · 73d
Cleared Dec 07, 1990
HEARING AID, UNITRON MODEL UM60-UH
K904576 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 59d
Cleared Dec 07, 1990
CONQUEST DIRECT FILLING COMPOSITE (DFC)
K904724 · KLE
Jeneric/Pentron, Inc.
Dental · 51d
Cleared Dec 07, 1990
QUALITONE ULTRA CANAL GENESIS
K904730 · ESD
Qualitone
Ear, Nose, Throat · 51d
Cleared Dec 07, 1990
INGLAT-O-BALL
K904774 · HHW
Milex Products, Inc.
Obstetrics & Gynecology · 46d
Cleared Dec 07, 1990
HDL CHOLESTEROL CONTROL
K904872 · JJY
Analytical Control Systems, Inc.
Chemistry · 38d
Cleared Dec 07, 1990
DIASTAT ENA PROFILE
K905190 · LJM
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 07, 1990
DIASTAT ANTI-SM
K905191 · LKP
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 07, 1990
DIASTAT ANTI-SM/RNP
K905192 · LKP
Shield Diagnostics, Ltd.
Immunology · 18d
Cleared Dec 06, 1990
TRACH-EZE
K903740 · BSY
Sorex Medical
Anesthesiology · 112d
Cleared Dec 06, 1990
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 104d
Cleared Dec 06, 1990
SOFTSHELL VENOUS RESERVOIR
K904040 · DTN
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Dec 06, 1990
CLINICAL CHEMISTRY CONTROL
K904075 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 93d
Cleared Dec 06, 1990
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES
K904143 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 90d
Cleared Dec 06, 1990
SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM
K904171 · DTR
Scimed
Cardiovascular · 86d