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
81217–81240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2000
INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST
K994406 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Aug 11, 2000
MAGIC MOBILITY 4 X 4 WHEELCHAIR
K000796 · ITI
Vestil Manufacturing Corp.
Physical Medicine · 151d
Cleared Aug 11, 2000
MICOR ANESTHESIA CONDUCTION KIT
K001940 · CAZ
Micor, Inc.
Anesthesiology · 46d
Cleared Aug 11, 2000
RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES:...
K002114 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 30d
Cleared Aug 11, 2000
GDC ULTRASOFT COIL
K002181 · HCG
Boston Scientific, Target
Neurology · 23d
Cleared Aug 11, 2000
NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
K002216 · LZA
Shanghai Champion Plastic Products...
General Hospital · 18d
Cleared Aug 11, 2000
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
K002217 · LZA
Shanghai Champion Plastic Products...
General Hospital · 18d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 270d
Cleared Aug 11, 2000
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
K994124 · LZA
Mapa Professional
General Hospital · 248d
Cleared Aug 10, 2000
RS-4M+MUSCLE STIMULATOR
K000114 · IPF
Rs Medical
Physical Medicine · 209d
Cleared Aug 10, 2000
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50...
K000913 · LYY
Handsafe Products Sdn. Bhd.
General Hospital · 141d
Cleared Aug 10, 2000
CARDIOSET (HARDWARE), MODEL HO4
K001091 · DXH
Next Millennium Software Solutions, Inc.
Cardiovascular · 128d
Cleared Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P,...
K001403 · CFR
Sigma Diagnostics, Inc.
Chemistry · 99d
Cleared Aug 10, 2000
THE FUGO BLADE
K001498 · NCR
Medisurg , Ltd.
Ophthalmic · 87d
Cleared Aug 10, 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Aug 10, 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT,...
K001565 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 83d
Cleared Aug 10, 2000
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · BZR
Mallard Medical, Inc.
Anesthesiology · 78d
Cleared Aug 10, 2000
PERMLASTIC 2
K001655 · ELW
Kerr Corp.
Dental · 71d
Cleared Aug 10, 2000
DC-TELL
K001799 · EBF
Austenal, Inc.
Dental · 57d
Cleared Aug 10, 2000
DC ZIRKON
K001815 · EIH
Austenal, Inc.
Dental · 56d
Cleared Aug 10, 2000
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
K001860 · IMC
Homedics, Inc.
Physical Medicine · 52d
Cleared Aug 10, 2000
CLEARFIL REPAIR
K001914 · KLE
Kuraray Company, Ltd.
Dental · 48d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953 · JWY
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · FPA
Abbott Laboratories
General Hospital · 38d