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
154369–154392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1984
EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT
K834550 · LFG
Syva Co.
Toxicology · 83d
Cleared Mar 19, 1984
OXYMIZER-PENDANT
K834588 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 81d
Cleared Mar 19, 1984
ACCUFLEX
K834590 · JQW
Micromedic Systems
Chemistry · 81d
Cleared Mar 19, 1984
SOPHEIA T3 EIA KIT
K840050 · CDP
Diagnostic Products Corp.
Chemistry · 73d
Cleared Mar 19, 1984
EMIT ST URINE METHADONE ASSAY
K840060 · DJR
Syva Co.
Toxicology · 70d
Cleared Mar 19, 1984
EMIT ST URINE PHENCYCLIDINE ASSAY
K840061 · LCM
Syva Co.
Toxicology · 70d
Cleared Mar 19, 1984
TOTAL BILIRUBIN
K840111 · CIG
Fisher Scientific Co., LLC
Chemistry · 69d
Cleared Mar 19, 1984
CURIETRON
K840127 · JAQ
Syncor Intl. Corp.
Radiology · 68d
Cleared Mar 19, 1984
EMIT ST URINE ETHYL ALCOHOL ASSAY
K840171 · DML
Syva Co.
Toxicology · 62d
Cleared Mar 19, 1984
LH QUIK RIA KIT
K840174 · CEP
Pacific Biotech, Inc.
Chemistry · 62d
Cleared Mar 19, 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840183 · FOZ
Parke-Davis Co.
General Hospital · 62d
Cleared Mar 19, 1984
EMIT ST SERUM BARBITURATE ASSAY
K840194 · DIS
Syva Co.
Toxicology · 61d
Cleared Mar 19, 1984
BLOOD UREA NITROGEN REAGENT SYS
K840213 · JGZ
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
CALCIUM REAGENT SYS
K840214 · CHZ
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
PHOSPHORUS REAGENT SYSTEM
K840215 · CEO
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
SODIUM/POTASSIUM REAGENT SYS
K840216 · JGT
Sclavo, Inc.
Chemistry · 60d
Cleared Mar 19, 1984
CONTROL COVER GOWN
K840229 · FYC
Kimberly-Clark Corp.
General Hospital · 59d
Cleared Mar 19, 1984
EMIT ST SERUM BENZODIAZEPINE ASSAY
K840236 · JXM
Syva Co.
Toxicology · 59d
Cleared Mar 19, 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840355 · FOZ
Parke-Davis Co.
General Hospital · 53d
Cleared Mar 19, 1984
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364 · JAA
Advanced Technology Laboratories, Inc.
Radiology · 53d
Cleared Mar 19, 1984
STOPCOCKS & EXTENSION TUBES
K840394 · FMG
American Pharmaseal Div. Ahsc
General Hospital · 49d
Cleared Mar 19, 1984
INFUSION SET-STERILE
K840409 · FPA
Loversan
General Hospital · 48d
Cleared Mar 19, 1984
SOLUTION ADMIN. SET STERILE
K840410 · FPA
Loversan
General Hospital · 48d
Cleared Mar 19, 1984
BLOOD & PLASMA ADMIN. DEV-STERILE
K840411 · BRZ
Loversan
General Hospital · 48d