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
97585–97608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1996
CLOSED FLUID COLLECTION SYSTEM
K961147 · GBX
B.Braun Medical, Inc.
General & Plastic Surgery · 71d
Cleared May 31, 1996
ACCUSIGN, BIOSIGN PCP
K961266 · LCM
Princeton BioMeditech Corp.
Toxicology · 59d
Cleared May 31, 1996
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
K961440 · FTL
Fusion Medical Technologies, Inc.
General & Plastic Surgery · 46d
Cleared May 31, 1996
LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
K961452 · KMF
Acme United Corp.
General & Plastic Surgery · 45d
Cleared May 31, 1996
SAS SHIGELLA SONNEI FORM II ANTISERUM
K961537 · GNB
Sa Scientific, Inc.
Microbiology · 39d
Cleared May 31, 1996
TONGUE CLEANER
K961660 · LCN
Jack Conrey
Dental · 31d
Cleared May 31, 1996
TBD AT-HOME PREGNANCY TEST
K961712 · LCX
Armkel, LLC
Chemistry · 29d
Cleared May 31, 1996
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
K961713 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 29d
Cleared May 30, 1996
IMX SELECT CHLAMYDIA
K936054 · LJC
Abbott Laboratories
Microbiology · 891d
Cleared May 30, 1996
VENTANNA ANTI-CD3 PRIMARY ANTIBODY
K941505 · DEH
Ventana Medical Systems, Inc.
Immunology · 793d
Cleared May 30, 1996
DIRECTIGEN MENINGITIS COMBO TEST
K952791 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 346d
Cleared May 30, 1996
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K954706 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 231d
Cleared May 30, 1996
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
K954951 · GZJ
Taylor Industries, Inc.
Neurology · 213d
Cleared May 30, 1996
BEHRING COAGULATION TIMER
K955278 · GGN
Behring Diagnostics, Inc.
Hematology · 195d
Cleared May 30, 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · MID
Shield Diagnostics, Ltd.
Immunology · 192d
Cleared May 30, 1996
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR...
K955460 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 183d
Cleared May 30, 1996
BREATHE RIGHT NASAL STRIP
K955711 · LWF
Cns, Inc.
Ear, Nose, Throat · 164d
Cleared May 30, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
K955905 · CEK
Solarcare Technologies Corp,Inc.
Chemistry · 153d
Cleared May 30, 1996
TAS HMT CONTROLS
K960234 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 134d
Cleared May 30, 1996
PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)
K960449 · DPS
Biosensor Corp.
Cardiovascular · 121d
Cleared May 30, 1996
H292 CELL CULTURE
K960909 · KIR
Neogenex
Microbiology · 86d
Cleared May 30, 1996
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K960983 · MAV
Medtronics Interventional Vascular
Cardiovascular · 80d
Cleared May 30, 1996
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
K961042 · LRH
Dade Microscan, Inc.
Microbiology · 77d
Cleared May 30, 1996
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE
K961236 · CDP
United Biotech, Inc.
Chemistry · 62d