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
145753–145776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1985
BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH
K854479 · FKP
Nipro Company, Ltd.
Gastroenterology & Urology · 39d
Cleared Dec 13, 1985
PORTASPIR II
K851560 · BTA
Roseburg SA
General & Plastic Surgery · 241d
Cleared Dec 13, 1985
HESSBURG LIGHT GUARD
K853035 · HOY
Visitec Co.
Ophthalmic · 148d
Cleared Dec 13, 1985
700-123 EYE SHADE
K853043 · HQY
Health Saver Products
Ophthalmic · 147d
Cleared Dec 13, 1985
KESTREL CONTACT LENS STORAGE CASE(NORYL)
K853728 · HPX
Ryder Intl. Corp.
Ophthalmic · 98d
Cleared Dec 13, 1985
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE)
K853729 · HPX
Ryder Intl. Corp.
Ophthalmic · 98d
Cleared Dec 13, 1985
THE GRONINGEN VOICE PROSTHESIS
K853940 · EWL
Hood Laboratories
Ear, Nose, Throat · 80d
Cleared Dec 13, 1985
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100
K853961 · HQE
Visitec Co.
Ophthalmic · 79d
Cleared Dec 13, 1985
IN-HOME VISION MONITORING KIT
K854047 · HOX
Rich-Larky Company, Inc.
Ophthalmic · 71d
Cleared Dec 13, 1985
RESNICK EMITTER, ARTIFICIAL LARYNX
K854158 · ESE
Dynamed Audio, Inc.
Ear, Nose, Throat · 63d
Cleared Dec 13, 1985
KEELER AMOILS SURGICAL ASTIGOMETER
K854256
Keeler Instruments, Inc.
Ophthalmic · 52d
Cleared Dec 13, 1985
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 51d
Cleared Dec 13, 1985
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · KDI
Gambro, Inc.
Gastroenterology & Urology · 49d
Cleared Dec 13, 1985
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
K854330 · HKI
Par Technology Park
Ophthalmic · 46d
Cleared Dec 13, 1985
RAICHEM CO2 REAGENT
K854544 · KHS
Reagents Applications, Inc.
Chemistry · 30d
Cleared Dec 13, 1985
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
K854580 · KNX
Coloplast A/S
Gastroenterology & Urology · 28d
Cleared Dec 13, 1985
HOLLOW FIBER DIALYZER
K854586 · KDI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 25d
Cleared Dec 13, 1985
DSL PROGESTERONE RIA (DSL #3400)
K854649 · JLS
Diagnostic Systems Laboratories, Inc.
Chemistry · 24d
Cleared Dec 13, 1985
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
K854650 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 24d
Cleared Dec 13, 1985
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · CGJ
American Dade
Chemistry · 24d
Cleared Dec 13, 1985
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE
K854724 · KIZ
Lifetrac, Inc.
Pathology · 21d
Cleared Dec 13, 1985
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564
K854776 · FNJ
Carrom Healthcare, Inc.
General Hospital · 14d
Cleared Dec 12, 1985
ANTI-EPSTEIN-BARR VIRUS KIT
K842662 · GNP
Amico Lab, Inc.
Immunology · 520d
Cleared Dec 12, 1985
NIFA NON INVASIVE FLUTTER ASSEMBLY
K844853 · KDQ
Emergency Management Products, Inc.
General Hospital · 363d