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
124249–124272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1990
IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED
K903288 · GEX
Iriderm Div.
General & Plastic Surgery · 88d
Cleared Sep 24, 1990
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
K903566 · JJY
Baxter Healthcare Corp
Immunology · 48d
Cleared Sep 24, 1990
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
K903567 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 48d
Cleared Sep 24, 1990
BARRIER FREE CEILING LIFT, MDLS HRS-1/2F,1/4F,1/6F
K903723 · FNG
Barrier Free Lifts, Inc.
General Hospital · 39d
Cleared Sep 24, 1990
SARAH COVENTRY SUNGLASSES
K903826 · HQY
R. N. Koch, Inc.
Ophthalmic · 35d
Cleared Sep 24, 1990
N. M. BEALE COMPANY VU-THRU WATER BOTTLE
K903834 · OCX
N.M. Beale Co., Inc.
Gastroenterology & Urology · 34d
Cleared Sep 24, 1990
PUMUCKL AND/OR DIETERLE
K904037 · HQZ
Pumuckl
Ophthalmic · 20d
Cleared Sep 24, 1990
MYOGLOBIN RIA TEST KIT
K904038 · DDR
Immuno Diagnostic Center, Inc.
Immunology · 20d
Cleared Sep 24, 1990
UC IMU A
K904125 · DER
Eucardio Laboratory, Inc.
Immunology · 18d
Cleared Sep 21, 1990
PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE
K895024 · FMI
Bio-Plexus, Inc.
General Hospital · 409d
Cleared Sep 21, 1990
WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
K895543 · LJS
Strato Medical Corp.
General Hospital · 373d
Cleared Sep 21, 1990
VEN-O-VAC BLOOD COLLECTION VACUUM TUBES
K900856 · JKA
Artefactos DE Vidrio S.A. DE C.V.
Chemistry · 210d
Cleared Sep 21, 1990
TEMPOROMANDIBULAR JOINT (TMJ) COIL
K902217 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Sep 21, 1990
E-Z FLO + SET
K902330 · FPA
Prn Services, Inc.
General Hospital · 120d
Cleared Sep 21, 1990
MILENIA PAP IRMA CATALOG #: MKPA1, X
K902937 · JFH
Diagnostic Products Corp.
Chemistry · 80d
Cleared Sep 21, 1990
MINICAP III CO2 DETECTOR
K903200 · CCK
Minesafety Appliances Co.
Anesthesiology · 60d
Cleared Sep 21, 1990
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K903377 · JAD
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Sep 21, 1990
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K903728 · CIG
Synermed, Inc.
Chemistry · 36d
Cleared Sep 21, 1990
SCANNING COT
K903901 · IYZ
Med-Tron Products, Inc.
Radiology · 29d
Cleared Sep 21, 1990
BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC
K904232 · LYY
Boston Medical Corp.
General Hospital · 9d
Cleared Sep 20, 1990
QUANTUM
K896408 · GZJ
Stressmaster Systems, Inc.
Neurology · 317d
Cleared Sep 20, 1990
OPTICA 120 ND:YAG SURGICAL LASER SYSTEM
K901710 · GEX
Xintec Corporation
General & Plastic Surgery · 160d
Cleared Sep 20, 1990
MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE
K902005 · JAA
Omega Medical Imaging, Inc.
Radiology · 139d
Cleared Sep 20, 1990
CUSTOMED CYSTO PACK I
K902274 · FAJ
Customed, Inc.
Gastroenterology & Urology · 122d