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
143833–143856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1986
CARDIOPULMONARY CANNULA TUBING
K861096 · DWF
Bio Medicus, Inc.
Cardiovascular · 58d
Cleared May 21, 1986
HYPERBARIC PENETRATION EXTENSION SET
K861315 · CBF
Cutter Laboratories, Inc.
Anesthesiology · 43d
Cleared May 21, 1986
LAERDAL POCKET MASK
K861401 · CBP
Laerdal Medical Corp.
Anesthesiology · 36d
Cleared May 21, 1986
THERAPAX HT 150T
K861431 · JAD
Old Delft Corp. of America
Radiology · 35d
Cleared May 21, 1986
INFANT MONITOR
K861484 · BZQ
Healthdyne, Inc.
Anesthesiology · 29d
Cleared May 21, 1986
REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
K861546 · EBF
Macrochem Corp.
Dental · 26d
Cleared May 21, 1986
ZEST MARK II (STANDARD & MINI)
K861561 · EGG
Zest Anchors, Inc.
Dental · 26d
Cleared May 21, 1986
CO2 LASER BRONCHOSCOPE SYSTEM
K861583 · LLO
Richard Wolf Medical Instruments Corp.
Anesthesiology · 22d
Cleared May 21, 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · EBF
3M Company
Dental · 15d
Cleared May 21, 1986
LASER SKIN MARKER AND MASK WHITE LOTION
K861772 · FZZ
Pacific Poly Crafts
General & Plastic Surgery · 14d
Cleared May 21, 1986
MEDSURG SINGLE USE BASIN SET
K861784
Medsurg Industries, Inc.
General & Plastic Surgery · 13d
Cleared May 21, 1986
BIOSIL H
K861787 · EJH
Degussa Dental, Inc.
Dental · 13d
Cleared May 21, 1986
VAPOFIL
K861839 · CAD
Southmedic, Inc.
Anesthesiology · 8d
Cleared May 20, 1986
VISIBLE-HERPES TM TEST SYSTEM
K854712 · GQO
Isolab, Inc.
Microbiology · 179d
Cleared May 20, 1986
SURGICOT STEAM TEST PACK
K854902 · FRC
Surgicot, Inc.
General Hospital · 162d
Cleared May 20, 1986
TELEFLEX TEFLON COATED GUIDEWIRE
K860258 · DQX
Teleflexmedical, Inc.
Cardiovascular · 116d
Cleared May 20, 1986
PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET
K860307 · DYB
Teleflex, Inc.
Cardiovascular · 112d
Cleared May 20, 1986
CYTOTECH CMV IGG EIA
K860493 · GQI
Cytotech, Inc.
Microbiology · 99d
Cleared May 20, 1986
1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507
K860621 · HGL
Impex Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared May 20, 1986
BECTON DICKINSON PCAINFUSER
K861007 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 63d
Cleared May 20, 1986
SENSITITRE AUTO ID PLATE, AP70
K861058 · JTO
Gibco Laboratories Life Technologies,...
Microbiology · 62d
Cleared May 20, 1986
MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS
K861112 · GEI
Valleylab, Inc.
General & Plastic Surgery · 56d
Cleared May 20, 1986
VWF-IX:AG CONTROL PLASMA
K861217 · GGP
American Bioproducts Co.
Hematology · 50d
Cleared May 20, 1986
IMPACT MODELS 701, 702 AND 703
K861272 · BTL
Impact Instrumentation, Inc.
Anesthesiology · 46d