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
144241–144264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 17, 1986
VAPORIZER SPACER
K860545 · CAD
Southmedic, Inc.
Anesthesiology · 63d
Cleared Apr 17, 1986
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
K860552 · HIR
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 62d
Cleared Apr 17, 1986
ES600 IMMUNOASSAY SYSTEM
K860647 · JJE
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Apr 17, 1986
PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT
K860653 · DZE
Otc/America
Dental · 55d
Cleared Apr 17, 1986
END TIDAL CO2 SAMPLING CIRCUIT
K860659 · BZO
Life Design Systems, Inc.
Anesthesiology · 52d
Cleared Apr 17, 1986
PHOTO CLEARFIL OPAQUER
K860708 · EBF
Kuraray Co.
Dental · 50d
Cleared Apr 17, 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736 · IZO
Fischer Imaging Corp.
Radiology · 49d
Cleared Apr 17, 1986
HITACHI 736
K860748 · JJE
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Apr 17, 1986
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
K860822 · FAJ
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 44d
Cleared Apr 17, 1986
EPIDURAL ANESTHESIA TRAY
K860833 · CAZ
Travenol Laboratories, S.A.
Anesthesiology · 43d
Cleared Apr 17, 1986
MALLORY/HEAD - PF ACETABULAR COMPONENT
K861114 · JDI
Biomet, Inc.
Orthopedic · 23d
Cleared Apr 17, 1986
ORTHOMED ORTHOPAEDIC FIXATION STAPLES
K861137 · JDR
Biomedical Exports, Inc.
Orthopedic · 22d
Cleared Apr 17, 1986
GAUZE SPONGES USP TYPE VII
K861215 · EFQ
Selomas, Inc.
General & Plastic Surgery · 17d
Cleared Apr 17, 1986
ACRYLIC SOLDER
K861239 · EBI
Parker Laboratories, Inc.
Dental · 15d