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
156625–156648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1983
SURGICAL/LID MARGIN COVER & EYELASH-
K831285 · HOD
Richard R. Anthony, M.D.
Ophthalmic · 44d
Cleared Jun 03, 1983
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
K831290 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Jun 03, 1983
CDS 2001 ARTIFICIAL KIDNEY
K831376 · KOC
Elmar Medical Systems, Ltd.
Gastroenterology & Urology · 37d
Cleared Jun 03, 1983
SINGLE NEEDLE SUBCLAVIAN VEIN ACCESS
K831401 · FIQ
Med-West, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 03, 1983
CRM-100 COLOR VIDEO CAMERA
K831412 · FET
Umi, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 03, 1983
SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260
K831440 · FIQ
Med-West, Inc.
Gastroenterology & Urology · 29d
Cleared Jun 03, 1983
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
K831482 · KOC
Terumo Medical Corp.
Gastroenterology & Urology · 25d
Cleared Jun 02, 1983
ADHESIVE TAPE/FIRST-BAND
K822824 · KGX
Leonard Joseph Co.
General & Plastic Surgery · 255d
Cleared Jun 02, 1983
IP SPECIFIC G
K830005 · DAA
Diagnostic Reagent Tech.
Chemistry · 150d
Cleared Jun 02, 1983
MOLNLYCKE MEPORE STERILE SELF-ADHESIVE
K830050 · NAD
Lada Intl., Inc.
General & Plastic Surgery · 143d
Cleared Jun 02, 1983
ANGIOSCOPE
K830084 · LYK
Trimedyne, Inc.
Cardiovascular · 142d
Cleared Jun 02, 1983
FLORET NEURO SPONGE
K830269 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 128d
Cleared Jun 02, 1983
LAPET & LAPWALL LAPAROTOMY SPONGES
K830271 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 128d
Cleared Jun 02, 1983
ACCU-LINE SURGICAL MARKER
K830298 · FZZ
Accu-Line
General & Plastic Surgery · 125d
Cleared Jun 02, 1983
SOILEAU TYTAN BOBBIN VENT TUBE
K830584 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 99d
Cleared Jun 02, 1983
REAL-TIME SPECTRUM ANALYZER
K830628 · DXG
Diagnostic Electronics Corp.
Cardiovascular · 93d
Cleared Jun 02, 1983
JERMYN OCCLUDERS KIT
K830737
Jermyn Specialties of California
Ophthalmic · 86d
Cleared Jun 02, 1983
CLERZ LUBRICATING & REWETTING EYE DROPS
K830740 · HPX
CooperVision, Inc.
Ophthalmic · 86d
Cleared Jun 02, 1983
PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
K830871 · HOC
Phakosystems, Inc.
Ophthalmic · 76d
Cleared Jun 02, 1983
AMPERCIDE DISINFECTANT ACCESSORY TO -
K830881 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 76d
Cleared Jun 02, 1983
160/260 SUCTION COAGULATOR
K830926 · GEI
Zimmer, Inc.
General & Plastic Surgery · 71d
Cleared Jun 02, 1983
BAKER JEJUNOSTOMY TUBE
K830989 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
BLAKEMORE TUBE
K830990 · KNT
Medovations, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 02, 1983
ESOPHAGEAL BOUGIES
K830991 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 65d