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
150457–150480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1984
VANISH ORTHODONTIC BRACKET
K844067 · EJF
A Company, Inc.
Dental · 36d
Cleared Nov 23, 1984
EIXO THERMUS HEATING PADS
K844224 · IMD
Eixo Thermus
Physical Medicine · 22d
Cleared Nov 23, 1984
ARK TONGUE CLEANER
K844291 · LCN
Arkay Co.
Dental · 18d
Cleared Nov 23, 1984
MEDI-TECH DILATATION CATHETERS
K844292 · LCN
Medi-Tech, Inc.
Dental · 18d
Cleared Nov 23, 1984
ORAL IRRIGATION TIP
K844318 · EFS
Pro Pulse, Inc.
Dental · 17d
Cleared Nov 21, 1984
OPERAID SURGICAL DRAIN
K841721 · HOZ
Jedmed Instrument Co.
Ophthalmic · 210d
Cleared Nov 21, 1984
OPERAID NUCLEUS
K841807 · KYG
Jedmed Instrument Co.
Ophthalmic · 204d
Cleared Nov 21, 1984
NORTA SILICONIZED LATEX BALLOON CATH.
K842420 · KOD
Beiersdorf, Inc.
Gastroenterology & Urology · 154d
Cleared Nov 21, 1984
AUTOMATED INTRAOCULAR SCISSORS
K842471 · HQE
Medical Instrument Development...
Ophthalmic · 149d
Cleared Nov 21, 1984
BRILLETTE MODEL
K842835 · HOI
Cillus Company, Inc.
Ophthalmic · 124d
Cleared Nov 21, 1984
SITE ANTERIOR CAPSULOTOMER
K843039 · HMX
Chiron Vision Corp.
Ophthalmic · 111d
Cleared Nov 21, 1984
HESLIN DISPOS. TUBING SET
K843041 · HQE
Innovative Surgical Products, Inc.
Ophthalmic · 111d
Cleared Nov 21, 1984
CRISTY/COTE
K843096 · HQG
Titmus Optical, Inc.
Ophthalmic · 106d
Cleared Nov 21, 1984
MAMIYA SLIT LAMP P-1
K843099 · HLI
Okada Corp.
Ophthalmic · 106d
Cleared Nov 21, 1984
BINOCULAR INDIRECT OPHTHALMOSCOPE
K843304 · HLI
Mentor O & O, Inc.
Ophthalmic · 90d
Cleared Nov 21, 1984
SUPERPETT
K843366 · KPS
Scanditronix, Inc.
Radiology · 85d
Cleared Nov 21, 1984
CILCOR OPHTHALMIC INSTRUMENTS
K843992 · HNR
Cilco, Inc.
Ophthalmic · 41d
Cleared Nov 21, 1984
QUEST BETA HCG ENZYME IMMUNOASSAY KIT
K844082 · JHI
Quidel Corp.
Immunology · 33d
Cleared Nov 21, 1984
SHURE GRIP TYING FORCEPS
K844129 · HNR
Mentor O & O, Inc.
Ophthalmic · 29d
Cleared Nov 21, 1984
PRISTINE
K844236 · KGO
Medical Dimensions
General Hospital · 20d
Cleared Nov 21, 1984
KONAN CLINIC MICROSCOPE CLM-100-150
K844323 · HRM
Keeler Instruments, Inc.
General & Plastic Surgery · 14d
Cleared Nov 20, 1984
RECOMED CARDIAC OUTPUT METER 236067-
K840439 · DXG
Litton Medical Electronics
Cardiovascular · 293d
Cleared Nov 20, 1984
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899 · DSI
Litton Medical Electronics
Cardiovascular · 266d
Cleared Nov 20, 1984
SUCTION CATHETER KIT
K843076 · BSY
Travenol Laboratories, S.A.
Anesthesiology · 106d