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
111865–111888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1993
VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800
K926108 · ITX
Vingmed Sound, Inc.
Radiology · 295d
Cleared Sep 24, 1993
DIAGNOSTIC INTRAVASCULAR CATHETER
K930758 · LYK
Applied Medical Resources
Cardiovascular · 224d
Cleared Sep 24, 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 213d
Cleared Sep 24, 1993
SYNELISA CENP-B ANTIBODIES
K931255 · LKJ
Elias U.S.A., Inc.
Immunology · 196d
Cleared Sep 24, 1993
IMMULITE BETA-2-MICROGLOBULIN
K931702 · JZG
Diagnostic Products Corp.
Immunology · 171d
Cleared Sep 24, 1993
SUCTION GUILLOTINE DEVICE
K932142 · FCK
Triton Technology, Inc.
Gastroenterology & Urology · 144d
Cleared Sep 24, 1993
TOXI*LAB LTD OPIATE SYSTEM
K932209 · LAI
Toxi-Lab, Inc.
Toxicology · 141d
Cleared Sep 24, 1993
ENZYMATIC CO2 REAGENT, MODIFICATION
K932267 · KHS
Intersect Systems, Inc.
Chemistry · 163d
Cleared Sep 24, 1993
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · KLS
Baxter Diagnostics, Inc.
Toxicology · 113d
Cleared Sep 24, 1993
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
K932850 · LLL
Helix Diagnostics, Inc.
Immunology · 106d
Cleared Sep 24, 1993
GC II AGAR WITH ISOVITALEX
K932882 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 102d
Cleared Sep 24, 1993
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
K933435 · JJY
Baxter Diagnostics, Inc.
Chemistry · 72d
Cleared Sep 24, 1993
OPTI-PLAST 5F PTA CATHETERS
K933483 · LIT
Vas-Cath, Inc.
Cardiovascular · 86d
Cleared Sep 24, 1993
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K933648 · JZG
Dupont Medical Products
Immunology · 59d
Cleared Sep 24, 1993
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
K933744 · JJX
Sa Scientific, Inc.
Chemistry · 57d
Cleared Sep 23, 1993
CARDIAC THERAPHY SYSTEM SCP 900
K921666 · LDD
Ppg Hellige B.V.
Cardiovascular · 534d
Cleared Sep 23, 1993
ANATOMICAL TYPE KNEE SYSTEM
K922859 · JWH
Osteo Technology, Inc.
Orthopedic · 476d
Cleared Sep 23, 1993
ENDOSI SUCTION IRRIGATOR
K923201 · GCJ
Armm, Inc.
General & Plastic Surgery · 450d
Cleared Sep 23, 1993
INSUFFLATION TUBING
K925691 · HIF
Mectra Labs, Inc.
Obstetrics & Gynecology · 315d
Cleared Sep 23, 1993
CENATOR TOTAL HIP SYSTEM
K925866 · JDI
Corin Orthopedic Products
Orthopedic · 308d
Cleared Sep 23, 1993
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
K926002 · JSS
Alamar Biosciences Laboratory, Inc.
Microbiology · 300d
Cleared Sep 23, 1993
POLYP SNARE NET W/MONOPOLAR CAUTERY
K926103 · GEI
United States Endoscopy Group, Inc.
General & Plastic Surgery · 294d
Cleared Sep 23, 1993
OMNI-MATRIX
K930151 · JEP
Innovative Technology , Ltd.
Dental · 254d
Cleared Sep 23, 1993
HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300
K930420 · FRF
Hunter Fan Co.
General Hospital · 240d