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
123721–123744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 26, 1990
COULTER DIRECT BILLRUBIN REAGENT
K905622 · CIG
Coulter Electronics, Inc.
Chemistry · 12d
Cleared Dec 24, 1990
SYSTEMS FLOW 2000
K902993 · KPL
Universal Hydrotech, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 24, 1990
EPISENSOR
K903224 · BSP
Palex Intl. SA
Anesthesiology · 154d
Cleared Dec 24, 1990
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
K903643 · GAW
Deknatel, Inc.
General & Plastic Surgery · 136d
Cleared Dec 24, 1990
PANOSOL II UVA-218
K904426 · FTC
National Biological Corp.
General & Plastic Surgery · 88d
Cleared Dec 24, 1990
PANOSOL II UVB-206
K904427 · FTC
National Biological Corp.
General & Plastic Surgery · 88d
Cleared Dec 24, 1990
PANOSOL II UAB-228
K904428 · FTC
National Biological Corp.
General & Plastic Surgery · 88d
Cleared Dec 24, 1990
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE
K904470 · EQH
Summit Technology, Inc.
Ear, Nose, Throat · 84d
Cleared Dec 24, 1990
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 89d
Cleared Dec 24, 1990
SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP
K904906 · GAW
Chathamborough Research Group, Inc.
General & Plastic Surgery · 60d
Cleared Dec 24, 1990
MODEL 2001, MODIFICATION
K905029 · FRN
Medfusion, Inc.
General Hospital · 54d
Cleared Dec 24, 1990
WILL-CERAM Y AND WILL -CERAM Y-1
K905323 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
WILL-CERAM W-1
K905324 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
MINIGOLD
K905326 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 24, 1990
HARMONY LINE ALLOYS
K905330 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 21, 1990
FEEDING TUBE
K896734 · FPD
Unoplast A/S
Gastroenterology & Urology · 386d
Cleared Dec 21, 1990
WILSON-COOK BALLOON DILATION CATHETERS
K900924 · KNQ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 297d
Cleared Dec 21, 1990
INDX DIP S TICKS
K901597 · LSQ
Intercare Diagnostics, Inc.
Microbiology · 260d
Cleared Dec 21, 1990
YUEFA DISPOSABLE SYRINGE
K902178 · FMF
Blue & Red Corp.
General Hospital · 220d
Cleared Dec 21, 1990
THE VISONIC DOME(TM)
K902306 · LYL
Vista Vision
Ophthalmic · 213d
Cleared Dec 21, 1990
MAMBA CONDOM (RUBBER LATEX)
K902907 · HIS
Rfsu
Obstetrics & Gynecology · 171d
Cleared Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 157d
Cleared Dec 21, 1990
HEARSET TELEPHONE HEARING SYSTEM
K903145 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 156d
Cleared Dec 21, 1990
MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER
K903209 · HES
Adler Instrument Co.
Obstetrics & Gynecology · 154d