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
153049–153072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1984
CROUP TENT FRAME
K842192 · CCQ
Home Run Treadmill Co.
Anesthesiology · 21d
Cleared Jun 25, 1984
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K842198 · BSY
American Pharmaseal Div. Ahsc
Anesthesiology · 21d
Cleared Jun 25, 1984
OXY-VAC
K842205 · BSY
Medi-Tech, Inc.
Anesthesiology · 21d
Cleared Jun 25, 1984
OXIDASE TEST STRIPS-OXIDASESURE
K842298 · JSF
Irvine Diagnostic Services
Microbiology · 14d
Cleared Jun 25, 1984
C.A.P.D. AUTOMATIC HEATER PDH 200
K842305 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 13d
Cleared Jun 22, 1984
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER
K831173 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIFICIAL KID-
K831174 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831175 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831176 · KOC
Erika, Inc.
Gastroenterology & Urology · 438d
Cleared Jun 22, 1984
GMP CIQ ELISA TEST KIT
K833275 · DAK
Gamma Medical Products, Inc.
Immunology · 275d
Cleared Jun 22, 1984
IN-THE-EAR HEARING AID MODEL
K833486 · ESD
Danavox, Inc.
Ear, Nose, Throat · 259d
Cleared Jun 22, 1984
SHEA MIDDLE EAR MICRODRILL
K833874 · ERL
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Jun 22, 1984
SHEA FOOTPLATE MICRODRILL
K833875 · ERL
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Jun 22, 1984
FLAME PHOTOMETERS
K834226 · JJO
Dr. Bruno Lange GmbH
Chemistry · 199d
Cleared Jun 22, 1984
EMIT D.A.U. URINE CANNABINOID CALIBRA
K834457 · DLJ
Syva Co.
Toxicology · 186d
Cleared Jun 22, 1984
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC
K840023 · DRS
American Bentley
Cardiovascular · 169d
Cleared Jun 22, 1984
DIATRON EASYTEST BLOOD GLUCOSE MONI
K840484 · CGA
Medivix, Inc.
Chemistry · 137d
Cleared Jun 22, 1984
REFLOCHECK-S
K840962 · CGA
Boehringer Mannheim Corp.
Chemistry · 108d
Cleared Jun 22, 1984
BLOOD COLLECTION SET, STERILE, DISPOS.
K841187 · BRZ
Marbex, Inc.
General Hospital · 94d
Cleared Jun 22, 1984
DIAGNON FOLATE 125I RIA KIT
K841302 · CGN
Diagnon Corp.
Chemistry · 84d
Cleared Jun 22, 1984
ELECTROLYTE ANALYZER SERA-210
K841424 · JGS
Horiba Instruments, Inc.
Chemistry · 77d
Cleared Jun 22, 1984
NOVA STAT CONTROL LEVELS 1/2/3
K841452 · JJY
Nova Biomedical Corp.
Chemistry · 74d
Cleared Jun 22, 1984
CHANGES IN THE CHEMICAL COMP. OF 5
K841464 · JIX
Nova Biomedical Corp.
Chemistry · 102d
Cleared Jun 22, 1984
HEARING AID MODEL 440PPC
K841473 · ESD
Radioear Corp.
Ear, Nose, Throat · 74d