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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98401–98424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1996
CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER
K955817 · DRF
Cordis Webster, Inc.
Cardiovascular · 90d
Cleared Mar 25, 1996
BRAUN HEMOSTASIS INTRODUCERS
K955820 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Mar 25, 1996
CORDIS VENTRICULAR ANTECHAMBER (VA)
K955832 · JXG
Cordis Corp.
Neurology · 90d
Cleared Mar 25, 1996
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER
K955839 · FOZ
Baxter Edwards
General Hospital · 90d
Cleared Mar 25, 1996
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL...
K955900 · HQD
Novavision, Inc.
Ophthalmic · 87d
Cleared Mar 25, 1996
STRYKER ADEL BASSINET
K960012 · FMS
Stryker Corp.
General Hospital · 83d
Cleared Mar 25, 1996
PROTEC ROLL GAUZE
K960093 · EFQ
Derivadas Degasa S.A. DE C.V.
General & Plastic Surgery · 74d
Cleared Mar 25, 1996
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT
K960148 · FAD
Cabot Medical Corp.
Gastroenterology & Urology · 74d
Cleared Mar 25, 1996
GERATHERM MERCUIRY FREE CLINICAL THERMOMETER
K960224 · FLK
Rg Ent., Inc.
General Hospital · 68d
Cleared Mar 25, 1996
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
K960291 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 63d
Cleared Mar 25, 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · JTZ
Remel, L.P.
Microbiology · 63d
Cleared Mar 25, 1996
A-DEC PERFORMER CONTROL UNIT
K960506 · EIA
A-Dec, Inc.
Dental · 49d
Cleared Mar 25, 1996
K3 BONE SCREW SYSTEM
K960533 · HWC
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 25, 1996
K2 BONE SCREW SYSTEM
K960537 · HWC
Kinetikos Medical, Inc.
Orthopedic · 47d
Cleared Mar 22, 1996
NORTHO BONE SCREW
K925872 · HWC
Northo Orthopedics
Orthopedic · 1219d
Cleared Mar 22, 1996
KERATIN PRIMARY ANTIBODY
K935161 · DEH
Ventana Medical Systems, Inc.
Immunology · 875d
Cleared Mar 22, 1996
ANTI-KERATIN-HMW PRIMARY ANTI-BODY
K941173 · DEH
Ventana Medical Systems, Inc.
Immunology · 739d
Cleared Mar 22, 1996
LEKSELL NEURO GENERATOR AND ACCESSORIES
K941823 · GXD
Elekta Instruments, Inc.
Neurology · 709d
Cleared Mar 22, 1996
BEST PREGNANCY TEST
K953606 · LCX
Ameritek, Inc.
Chemistry · 233d
Cleared Mar 22, 1996
HEMATIL 18 (H-18)
K953643 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 231d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (SM)
K954896 · LKP
Hycor Biomedical, Inc.
Immunology · 185d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · LKO
Hycor Biomedical, Inc.
Immunology · 185d
Cleared Mar 22, 1996
SCHUHLI IMPLANT SYSTEM
K954963 · HRS
Synthes (Usa)
Orthopedic · 144d
Cleared Mar 22, 1996
ISOTRON III, ISOTRON IV
K955387 · LIH
Excel Tech. , Ltd.
Neurology · 121d