Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
144433–144456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 20, 1986
QMED SYSTEM 2150
K861437 · DXG
Qmed, Inc.
Cardiovascular · 33d
Cleared May 20, 1986
QUADRA-TITER (TM) I.D. (MODIFICATION)
K861774 · JSS
Microtech Medical Systems, Inc.
Microbiology · 13d
Cleared May 20, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE
K861791 · JSK
Flow Laboratories, Inc.
Microbiology · 11d
Cleared May 20, 1986
LAMB SERUM - STERILE FILTERED
K861809 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
CHICKEN SERUM - STERILE FILTERED
K861810 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
MOUSE SERUM - STERILE FILTERED
K861811 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HUMAN SERUM - STERILE FILTERED
K861812 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HUMAN AB SERUM - STERILE FILTERED
K861813 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
RHESUS MONKEY SERUM - STERILE FILTERED
K861814 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE
K861815 · KIS
Hazleton Research Products, Inc.
Pathology · 11d