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
151489–151512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 17, 1984
LITHIUM REAGENT
K841847 · JJO
Reagent Laboratory, Inc.
Toxicology · 121d
Cleared Aug 17, 1984
HOSPITAL'S-SPEC
K842014 · HIB
Merex Co.
Obstetrics & Gynecology · 91d
Cleared Aug 17, 1984
FLU MET 2
K842088 · FPA
Venusa , Ltd.
General Hospital · 85d
Cleared Aug 17, 1984
ACTH STANDARD MATRIX
K842099 · JIT
Diagnostic Systems Laboratories, Inc.
Chemistry · 84d
Cleared Aug 17, 1984
CHOLESTEROL ASSSAY KIT
K842160 · CHH
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 79d
Cleared Aug 17, 1984
AIMED DISPOS. INJECTION NEEDLE
K842230 · GAA
Tech-Cons Ltd., Intl.
General & Plastic Surgery · 73d