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
151153–151176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1984
ORTHODONTIC WIRE
K843722 · DZC
Arthur L. Wool
Dental · 46d
Cleared Nov 09, 1984
UNITEK CONVERTIBLE CAP REMOVER TOOL
K843742 · JEX
Unitek Corp.
Dental · 45d
Cleared Nov 09, 1984
BEHIND-THE-EAR 123 VTH
K843791 · ESD
Danavox, Inc.
Ear, Nose, Throat · 43d
Cleared Nov 09, 1984
RIONET HEARING AID HB-73
K844000 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 09, 1984
TRIGLYCERIDE REAGENT
K844032 · CDT
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 09, 1984
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
K844047 · JIT
Fisher Diagnostics
Chemistry · 23d
Cleared Nov 09, 1984
VOLUMATIC
K844169 · KCD
Glaxo, Inc.
Ear, Nose, Throat · 15d
Cleared Nov 09, 1984
INORGANIC PHOSPHORUS REAGENT SET
K844182 · CEO
Livonia Diagnostics, Inc.
Chemistry · 14d
Cleared Nov 08, 1984
COMFEEL POWDER
K834343 · KOZ
Coloplast A/S
General & Plastic Surgery · 332d
Cleared Nov 08, 1984
LUER LOCKING ADAPTER(MATERIAL CHANGE)
K840815 · FOZ
Quinton, Inc.
General Hospital · 255d
Cleared Nov 08, 1984
PORTABLE NURSING UNIT TERMINAL
K841246 · DXN
Ncr Corp.
Cardiovascular · 230d
Cleared Nov 08, 1984
CO2 SURGICAL LASER SYSTEM XML-10
K841860 · EWG
Xanar, Inc.
Ear, Nose, Throat · 188d
Cleared Nov 08, 1984
EZ EYE DROP AID
K841896
Buckman Co., Inc.
Ophthalmic · 185d
Cleared Nov 08, 1984
IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS
K842217 · JAA
Micro Consultants, Inc.
Radiology · 157d
Cleared Nov 08, 1984
TPN/HYPERALIMENTATION TRAY
K842644 · FRG
Deroyal Industries, Inc.
General Hospital · 121d
Cleared Nov 08, 1984
SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT
K842690 · FFT
Synectics AB
Gastroenterology & Urology · 121d
Cleared Nov 08, 1984
DORR HIP PROSTHESIS, ACETABULAR COMPON
K842893 · JDL
Carbomedics, Inc.
Orthopedic · 108d
Cleared Nov 08, 1984
AQUAPHOR R GAUZE
K842967 · FRO
Beiersdorf, Inc.
General & Plastic Surgery · 104d
Cleared Nov 08, 1984
ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
K843139 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 91d
Cleared Nov 08, 1984
ISOLATE ADHESIVE BANDAGE FOR DRY WOUND
K843140 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 91d
Cleared Nov 08, 1984
STENOSCOP
K843235 · JAA
Cgr Medical Corp.
Radiology · 84d
Cleared Nov 08, 1984
KETRONIC MEDAX - N
K843288 · IYX
Ketronic, Inc.
Radiology · 79d
Cleared Nov 08, 1984
ASC 4080 SYSTEM
K843634 · IKE
Atlantis Scientific Corp.
Physical Medicine · 52d
Cleared Nov 08, 1984
DUAL CHENNEL BRAIN ACTIVITY MONITOR
K843808 · OLT
Datex Division Instrumentarium Corp.
Neurology · 42d