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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
152833–152856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1984
HESUNG'S HYPERDERMIC NEEDLES
K841565 · FMI
Amkor Trading Co.
General Hospital · 91d
Cleared Jul 17, 1984
HESUNG DISPOSABLE SYRINGE
K841566 · FMF
Amkor Trading Co.
General Hospital · 91d
Cleared Jul 17, 1984
GSR, 126, EEG 130-TEMP. 132, EMG 133
K841895 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 17, 1984
LORAD
K842102 · IZH
Lorad Medical Systems, Inc.
Radiology · 53d
Cleared Jul 17, 1984
UNIVERSAL EXAMINATION TABLE
K842108 · GZO
Engineering Dynamics Corp.
Radiology · 49d
Cleared Jul 17, 1984
SPOT-FILM DEVICE 8835
K842184 · IXL
General Electric Co.
Radiology · 46d
Cleared Jul 17, 1984
ORTHO BRAND HOME PREGNANCY TEST
K842265 · LCX
Advanced Care Products
Chemistry · 40d
Cleared Jul 17, 1984
EEG 130
K842288 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 17, 1984
VH820 HUMIDIFIER
K842340 · BTT
Bear Medical Systems, Inc.
Anesthesiology · 33d
Cleared Jul 17, 1984
TEMPERATURE 132
K842353 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 17, 1984
EMG MODEL 133
K842354 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 16, 1984
MINI-DOPPLER ES-100
K840542 · JOP
Hayashi Denki Co., Ltd.
Cardiovascular · 159d
Cleared Jul 16, 1984
RELAX STRESS REDUCTION SYS
K841128 · HCC
Synapse Software Corp.
Neurology · 122d
Cleared Jul 16, 1984
ADAPTOR HR-3000 REUSE
K841153 · LIF
Colorado Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 16, 1984
BANANA CUFF
K841558 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 91d
Cleared Jul 16, 1984
BRIMFIELD FIBEROPTIC LIGHT SCOURCE
K841731 · EQH
Brimfield Scientific Instruments
Ear, Nose, Throat · 81d
Cleared Jul 16, 1984
RADCAL MODEL 4046 RADIONUCLIDE CALIBR
K841785 · KPT
Radcal Corp.
Radiology · 77d
Cleared Jul 16, 1984
RADCAL MODEL 4051 RADIONUCLIDE CALIBRA
K841786 · KPT
Radcal Corp.
Radiology · 77d
Cleared Jul 16, 1984
RADCAL MODEL 4050 RADIONUCLIDE CALIB
K841787 · KPT
Radcal Corp.
Radiology · 77d
Cleared Jul 16, 1984
MAXICAMERA 400T W/BODY CONTOUR TOMOGRA
K841996 · JAM
General Electric Co.
Radiology · 61d
Cleared Jul 16, 1984
CITOJECT CARTRIDGE SYRINGE
K842006 · EJI
Miles Laboratories, Inc.
Dental · 60d
Cleared Jul 16, 1984
ATAGO URINE SPECIFIC GRAVITY & SERUM
K842168 · JRE
Kyoto Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 16, 1984
SUNMASTER
K842276 · IOB
Mt. Hood Mfr., Inc.
Physical Medicine · 38d
Cleared Jul 13, 1984
DISPOSA-SPEC
K840593 · ERA
Plasti-Products, Inc.
Ear, Nose, Throat · 155d