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

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175,820 results
140977–141000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1987
WARM WEIGH MODEL N-10 INFANT SCALE
K870888 · FRW
Air-Shields, Inc.
General Hospital · 12d
Cleared Mar 17, 1987
T-CONNECTORS 014500/014501/014502/014503-120
K870912 · FPK
Clinical Connections, Inc.
General Hospital · 11d
Cleared Mar 17, 1987
INJECTION SITE #014456-120
K870913 · FPA
Clinical Connections, Inc.
General Hospital · 11d
Cleared Mar 17, 1987
PAD, BED LINEN PROTECTIVE
K870925 · KME
Quality Disposables, Inc.
General Hospital · 8d
Cleared Mar 17, 1987
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940 · FPA
Travenol Laboratories, S.A.
General Hospital · 8d
Cleared Mar 17, 1987
COAG-A-MATE(R) XC
K870960 · JPA
Organon Teknika Corp.
Hematology · 7d
Cleared Mar 16, 1987
COCAINE METABOLITE ROCHE(R) EIA
K863843 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 166d
Cleared Mar 16, 1987
VISION(TM) CRP
K864131 · DCK
Abbott Laboratories
Immunology · 146d
Cleared Mar 16, 1987
MORPHINE ROCHE (R) EIA TEST
K864168 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 143d
Cleared Mar 16, 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · CAC
Sherwood Medical Co.
Anesthesiology · 131d
Cleared Mar 16, 1987
LIFEWATCH(R) PORTABLE MONITORING SYSTEM
K864419 · BZQ
Lifewatch Systems, Inc.
Anesthesiology · 126d
Cleared Mar 16, 1987
STAVIP 3000
K864436 · JJN
Roseburg SA
Chemistry · 124d
Cleared Mar 16, 1987
PFLEX EM(TM) (EXERCISE MONITOR)
K864719 · BWF
Health Products, Inc.
Anesthesiology · 103d
Cleared Mar 16, 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · DPS
Mennen Medical, Inc.
Cardiovascular · 96d
Cleared Mar 16, 1987
RESUBMISSION OF THE KLEERZIT REAGENT
K864866 · JKA
Advanced Biomedical Methods, Inc.
Chemistry · 95d
Cleared Mar 16, 1987
MEVACHECK
K864910 · IYE
Magus Microcontrollers, Inc.
Radiology · 91d
Cleared Mar 16, 1987
CYTOSCAN
K864955 · LNJ
Image Recognition Systems , Ltd.
Pathology · 88d
Cleared Mar 16, 1987
IQ FTI IMMUNOASSAY
K865104 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 76d
Cleared Mar 16, 1987
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
K870027 · CCQ
Salter Labs
Anesthesiology · 70d
Cleared Mar 16, 1987
RMI VENOUS DRAINAGE CANNULA
K870109 · DWF
Research Medical, Inc.
Cardiovascular · 63d
Cleared Mar 16, 1987
(MERIFLUOR)TM-CRYPTOSPORIDIUM
K870171
Meridian Diagnostics, Inc.
Microbiology · 61d
Cleared Mar 16, 1987
ARIES TAPERED SHEATH
K870189 · DYB
Aries Medical, Inc.
Cardiovascular · 59d
Cleared Mar 16, 1987
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363 · KHG
Trace Scientific , Ltd.
Hematology · 47d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 46d