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
152329–152352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1984
PRO-SOFT DEHYDRANT
K842863 · PPM
Anatech, Ltd.
Pathology · 29d
Cleared Aug 21, 1984
SEP PROGRAMMER FOR PUCK U & UD FILMCHANG
K842903 · IZP
Elema-Schonander, Inc.
Radiology · 28d
Cleared Aug 21, 1984
PUCK U & UD CUTFILM CHANGERS
K842911 · KPX
Elema-Schonander, Inc.
Radiology · 29d
Cleared Aug 21, 1984
ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL
K842953 · HRR
All-Hands Medical Supply, Inc.
Orthopedic · 25d
Cleared Aug 21, 1984
REFRAX MOUNTING MEDIUM
K842986 · LEB
Anatech, Ltd.
Pathology · 22d
Cleared Aug 20, 1984
MICROSURGICAL CO2 LASER SYS - 4100
K840406 · GEX
Bio Quantum Technologies, Inc.
General & Plastic Surgery · 202d
Cleared Aug 20, 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 145d
Cleared Aug 20, 1984
ASSURE-BREATHABLE PANTY LINERS/UNSCENT
K841311 · HHD
Personal Products Co.
Obstetrics & Gynecology · 143d
Cleared Aug 20, 1984
ASSURE-BREATHABLE PANTY LINERS/SCENT
K841312 · HHL
Personal Products Co.
Obstetrics & Gynecology · 143d
Cleared Aug 20, 1984
MEDICAL EMERG. STABILIZER OBJECT/BODY
K842254
Walter Ansted Co.
General & Plastic Surgery · 74d
Cleared Aug 20, 1984
AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY
K842542 · FMI
American Pharmaseal Div. Ahsc
General Hospital · 49d
Cleared Aug 20, 1984
MINIMUM ESSENTIAL MED W/L-GLUTAMINE
K842776 · KIT
Sigma Chemical Co.
Microbiology · 35d
Cleared Aug 20, 1984
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
K843065 · KZI
Otisville Biotech, Inc.
Microbiology · 14d
Cleared Aug 20, 1984
BIOTIS CIN AGAR PLATES
K843066 · JSI
Otisville Biotech, Inc.
Microbiology · 14d
Cleared Aug 20, 1984
CUSHION-FLEX TM
K843169 · BSJ
Life Design Systems, Inc.
Anesthesiology · 7d
Cleared Aug 20, 1984
NERVE STIMULATOR Q10
K843175 · BXN
Acm Systems
Anesthesiology · 7d
Cleared Aug 18, 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · HRX
American Edwards Laboratories
Orthopedic · 121d
Cleared Aug 17, 1984
MICROPOROUS MED. ADHESIVE TAPE
K840447 · KGX
Lectec Corp.
General & Plastic Surgery · 198d
Cleared Aug 17, 1984
MICROPOROUS HYPOALLERGENIC
K840946 · KGW
Gainor Medical
General & Plastic Surgery · 165d
Cleared Aug 17, 1984
CLOTH-HYPOALLERGENIC
K840947 · KGX
Gainor Medical
General & Plastic Surgery · 165d
Cleared Aug 17, 1984
CLEAR PLASTIC-HYPOALLERGENIC
K840949 · KGX
Gainor Medical
General & Plastic Surgery · 165d
Cleared Aug 17, 1984
FOX POST NASAL BALLOON CATHETER
K841040 · EMX
Inmed Corp.
Ear, Nose, Throat · 158d
Cleared Aug 17, 1984
FINE NEEDLE ASPIRATION DEVICE
K841275 · DRM
Gyneco, Inc.
Cardiovascular · 143d
Cleared Aug 17, 1984
TECHNICARE 248 SL & 260SL
K841817 · IYO
Technicare Corp.
Radiology · 108d