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
145681–145704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 24, 1985
SCALPEL HANDLE
K854858 · GDZ
Medelec Intl. Corp.
General & Plastic Surgery · 19d
Cleared Dec 24, 1985
BLADES, SCALPEL STAINLESS STEEL
K854859 · GES
Medelec Intl. Corp.
General & Plastic Surgery · 19d
Cleared Dec 24, 1985
BLADES, SCALPEL CARBON STEET
K854860 · GES
Medelec Intl. Corp.
General & Plastic Surgery · 19d
Cleared Dec 24, 1985
BI-POLAR FORCEPS
K854864 · GEI
Birtcher Corp.
General & Plastic Surgery · 19d
Cleared Dec 24, 1985
RANDALL CURETTE
K854888 · FZS
Euro-Med Intl.
General & Plastic Surgery · 18d
Cleared Dec 24, 1985
RULER
K854892 · FTY
Euro-Med Intl.
General & Plastic Surgery · 18d
Cleared Dec 24, 1985
KEYES SKIN PUNCH
K854893
Euro-Med Intl.
General & Plastic Surgery · 18d
Cleared Dec 24, 1985
NOVAK CURETTE
K854899 · FZS
Euro-Med Intl.
General & Plastic Surgery · 18d
Cleared Dec 24, 1985
EPISIOTOMY SCISSORS
K854900
Euro-Med Intl.
General & Plastic Surgery · 18d
Cleared Dec 24, 1985
VENTILATOR PRESSURE ALARM MODEL VPA-100
K854934 · CAP
Respiratory Support Products, Inc.
Anesthesiology · 14d
Cleared Dec 23, 1985
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
K852680 · HET
Multigon Industries, Inc.
Obstetrics & Gynecology · 181d
Cleared Dec 23, 1985
DIRECT ELISA FOR HERPES SIMPLEX VIRUS
K853307 · GQN
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 138d
Cleared Dec 23, 1985
SHAH SELF-CLEARING MASTOID SUCTION TUBE
K853589 · JZF
Downs Surgical , Ltd.
Ear, Nose, Throat · 118d
Cleared Dec 23, 1985
CRITIC C LEVEL I & II
K853943 · JJY
Dimension Diagnostics
Immunology · 90d
Cleared Dec 23, 1985
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A
K854135 · IYO
Hewlett-Packard Co.
Radiology · 74d
Cleared Dec 23, 1985
CERAM-ETCH
K854494 · EBC
Gresco Products, Inc.
Dental · 41d
Cleared Dec 23, 1985
EPIDURAL ANESTHESIA TRAY
K854518 · CAZ
Omnis Surgical, Inc.
Anesthesiology · 41d
Cleared Dec 23, 1985
BIOGRAM
K854521 · JTZ
Giles Scientific, Inc.
Microbiology · 41d
Cleared Dec 23, 1985
TRANSPORT CULTURE MEDIA
K854715 · JSM
Hillcrest Biologicals
Microbiology · 31d
Cleared Dec 23, 1985
MICRO-MAT SYSTEM
K854962 · GKJ
Ulster Scientific, Inc.
Hematology · 12d
Cleared Dec 20, 1985
TENS
K850006
Zimmer Elektromedizin GmbH
Neurology · 352d
Cleared Dec 20, 1985
SUBDERM TM
K853635 · EGJ
General Medical Co.
Physical Medicine · 112d
Cleared Dec 20, 1985
AUDTEX 85
K853895 · ESD
Cami, Inc.
Ear, Nose, Throat · 91d
Cleared Dec 19, 1985
O.M.S. ULTRA-PHACO
K844373 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 401d