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
153073–153096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1984
HEARING AID MODEL P500
K841474 · ESD
Radioear Corp.
Ear, Nose, Throat · 74d
Cleared Jun 22, 1984
HEARING AID MODEL M400
K841475 · ESD
Radioear Corp.
Ear, Nose, Throat · 74d
Cleared Jun 22, 1984
SCOTCHBOND LIGHT CURED DENTAL ADHES
K841550 · EBF
3M Company
Dental · 67d
Cleared Jun 22, 1984
OSSEOINTEGRATED FIXTURES-TISSUE INTEGR
K841551 · DZE
Bofors Nobelpharma, Inc.
Dental · 67d
Cleared Jun 22, 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · DHN
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Jun 22, 1984
DENTURE CLEANSER
K841801 · EFT
Miracle Clean, Inc.
Dental · 52d
Cleared Jun 22, 1984
OPTIMATE IGM TEST
K841814 · DFT
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
OPTIMATE IGG TEST
K841816 · DEW
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · JHI
Travenol Laboratories, S.A.
Chemistry · 51d
Cleared Jun 22, 1984
PREG-BETA ONE HOUR TUBE TEST
K841853 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 50d
Cleared Jun 22, 1984
BHCG RIA
K841854 · JHI
Syncor Intl. Corp.
Chemistry · 50d
Cleared Jun 22, 1984
HEART-CHECK ECG TRANSMITTER
K841875
Physio Ventures, Inc.
Cardiovascular · 46d
Cleared Jun 22, 1984
PARAMAX IRON REAGENT
K841886 · JIY
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
PARAMAX IRON BLANK REAGENT
K841887 · JIY
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
ABBOTT PROJECT I
K841916 · JJE
Abbott Laboratories
Chemistry · 44d
Cleared Jun 22, 1984
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
HANKS BALANCED SALTS-HBSS H2387
K842002 · KIT
Sigma Chemical Co.
Pathology · 37d
Cleared Jun 22, 1984
CHLORIDE TEST KIT
K842011 · CHJ
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Jun 22, 1984
TIBC PRETREATMENT KIT
K842019 · JQE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Jun 22, 1984
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
K842025 · JGS
Hi Chem, Inc.
Chemistry · 35d
Cleared Jun 22, 1984
ELVI 165 PROTEO SEROSKOP
K842056 · JQT
Logos Scientific, Inc.
Chemistry · 31d
Cleared Jun 22, 1984
ADP ANA IFA TEST
K842183 · DHN
Apple Diagnostic Products
Immunology · 21d
Cleared Jun 22, 1984
PLAIN JANE SERIES WHEELCHAIR
K842232 · IOR
Invacare Corp.
Physical Medicine · 17d