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
144817–144840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1986
GREENLEAF SMART POLYGRAPH PROGRAM
K854355 · BZQ
Greenleaf Science Corp.
Anesthesiology · 171d
Cleared Apr 18, 1986
REUMAGEN ASL
K854991 · GTQ
Biokit USA, Inc.
Microbiology · 127d
Cleared Apr 18, 1986
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K860162 · FRN
Travenol Laboratories, S.A.
General Hospital · 91d
Cleared Apr 18, 1986
SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
K860354 · JCF
Sepratech Corporation C/O Keller and...
Hematology · 78d
Cleared Apr 18, 1986
EBI HAND MASSAGING PUMP (HMP)
K860632 · IRP
Electro-Biology, Inc.
Physical Medicine · 57d
Cleared Apr 18, 1986
BIODEX SYSTEM
K860821 · IKK
Biodex Corp.
Physical Medicine · 45d
Cleared Apr 18, 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · KTN
Gamma Biologicals, Inc.
Immunology · 31d
Cleared Apr 18, 1986
NAUTILUS LEG EXTENSION TESTING & REHABILITATION
K861206 · IKK
Nautilus Sports/Medical Industries, Inc.
Physical Medicine · 18d
Cleared Apr 18, 1986
AQUA ARK, IMMERSION HYDROBATH
K861218 · ILJ
Aqua Ark, Inc.
Physical Medicine · 18d
Cleared Apr 18, 1986
BASIC LIGHT
K861289 · KZF
Burton Medical Products Corp.
General Hospital · 11d
Cleared Apr 18, 1986
LYFO-KWIK (TM) COAGULASE PLASMA
K861312 · JTL
Micro-Bio-Logics
Hematology · 10d
Cleared Apr 18, 1986
HUMAN LUNG CARCINOMA CELLS (A549)
K861373 · KIR
Viromed Laboratories, Inc.
Pathology · 7d
Cleared Apr 18, 1986
SOLEX THERAPEUTIC PAD
K861383 · IRT
Intl. Diathermics Research, Inc.
Physical Medicine · 4d
Cleared Apr 17, 1986
6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
K844772 · ITX
Philips Medical Systems, Inc.
Radiology · 498d
Cleared Apr 17, 1986
EM ELECTRODE
K853774 · DRX
Electromed Intl., Ltd.
Cardiovascular · 219d
Cleared Apr 17, 1986
OMRON DIGITAL BP MONITOR HEM-700CP
K854201 · DXN
Omron Tateisi Electronics Co.
Cardiovascular · 184d
Cleared Apr 17, 1986
REI-90/90 RADIOGRAPHIC TABLE
K854478 · IXR
Radiological Engineering, Inc.
Radiology · 161d
Cleared Apr 17, 1986
BIOMECCA CENTRAL CS1
K854639 · DRT
Biomecca Australia , Ltd.
Cardiovascular · 149d
Cleared Apr 17, 1986
SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220
K860118 · EFT
Northern Electric Co. Div. of Sunbeam...
Dental · 94d
Cleared Apr 17, 1986
VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID
K860170 · ESD
Voroba Technologies Assoc.
Ear, Nose, Throat · 90d
Cleared Apr 17, 1986
CARDIOFAX ECG-6353
K860212 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1986
SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM
K860219 · OLV
Grass-Telefactor Product Group
Neurology · 85d
Cleared Apr 17, 1986
CNS-EP SYSTEM AND EP 1.0 SOFTWARE
K860240 · GWF
Cns, Inc.
Neurology · 84d
Cleared Apr 17, 1986
THE CELL CARE SYSTEM
K860537 · KMI
The Clell Corp.
General Hospital · 65d