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
150097–150120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1985
INCUS PROSTHESIS
K844961 · ETB
Richards Medical Co., Inc.
Ear, Nose, Throat · 67d
Cleared Feb 26, 1985
CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS
K845030 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 61d
Cleared Feb 26, 1985
STERILE SUTURE REMOVAL KIT
K850325 · KDD
Excel Health Care Products
General & Plastic Surgery · 29d
Cleared Feb 26, 1985
STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
K850326 · KKX
Excel Health Care Products
General Hospital · 29d
Cleared Feb 26, 1985
PALL GAS LINE GUARDIAN FILTER
K850327 · CAH
Pall Biomedical Products Co.
General Hospital · 29d
Cleared Feb 26, 1985
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · BTM
Vital Signs, Inc.
Anesthesiology · 21d
Cleared Feb 26, 1985
RENAL BIOPSY TRAY
K850438 · KNW
Packaging Technologies, Inc.
Gastroenterology & Urology · 21d
Cleared Feb 26, 1985
CONCEPT CAMERA DRAPE
K850462
Concept, Inc.
General & Plastic Surgery · 20d
Cleared Feb 26, 1985
ATTENDS INCONTINENT UNDERGARMENT
K850611 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 11d
Cleared Feb 25, 1985
A1 SYSTEME 8201/2
K841803 · GKL
Med USA
Hematology · 300d
Cleared Feb 25, 1985
GL ULTRASOUND Z/SL 8300
K843205 · IYO
Gl Ultrasound , Ltd.
Radiology · 195d
Cleared Feb 25, 1985
ENDOCYTE
K843941 · HFE
Gyneco, Inc.
Obstetrics & Gynecology · 139d
Cleared Feb 25, 1985
TENS-AID PREMIUM ELECTRODES
K843964 · GXY
Staodynamics, Inc.
Neurology · 137d
Cleared Feb 25, 1985
EUB-40
K844128 · JAF
Hitachi Medical Corp. of America
Radiology · 125d
Cleared Feb 25, 1985
LINEAR SCANNER PROBE ELSCINT LTD. TL-35
K844189 · IYP
Elscint, Inc.
Radiology · 118d
Cleared Feb 25, 1985
SUPPLEMENTAL FEEDING SYSTEM
K844297 · HGY
Medela, Inc.
Obstetrics & Gynecology · 119d
Cleared Feb 25, 1985
1URO-LOG HOME DIAGNOSTIC PACK
K844338 · FFG
Epcom Medical Systems, Inc.
Gastroenterology & Urology · 109d
Cleared Feb 25, 1985
YN CO2 LASER SYSTEM 30W
K844431 · HHR
Cryomedics, Inc.
Obstetrics & Gynecology · 101d
Cleared Feb 25, 1985
MEDCOLATOR MODEL HVX
K844580 · IPF
Medco Products, Co., Inc.
Physical Medicine · 94d
Cleared Feb 25, 1985
VPS 2250, CSU2250 & VFU 2250
K844659 · GWE
Madsen Electronics (Canada) , Ltd.
Neurology · 91d
Cleared Feb 25, 1985
CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON
K844671 · KET
Corning Medical & Scientific
Pathology · 87d
Cleared Feb 25, 1985
METHYL GREEN-PYRONIN STAIN PROCEDURE HT70
K844808 · HZA
Sigma Chemical Co.
Pathology · 76d
Cleared Feb 25, 1985
HEPES BUFFER IM IN NORMAL SALINE
K844877 · KIP
Hazleton Research Products, Inc.
Pathology · 70d
Cleared Feb 25, 1985
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
K844878 · KIP
Hazleton Research Products, Inc.
Microbiology · 70d