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
167473–167496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1980
NORDICLAB PROGESTERONE RIA TEST
K800922 · JLS
Nordiclab Intl.
Chemistry · 23d
Cleared May 14, 1980
PAPER-PAK OB PADS
K800952 · HHD
Paper-Pak Products, Inc.
Obstetrics & Gynecology · 21d
Cleared May 14, 1980
LARGE VOLUME ENEMA CONTAINER DISPOSABLE
K800959 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
1500 ML DISPOSABLE ENEMA CONTAINER(1110)
K800960 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
ENEMA CONTAINER DISP. FOR EMEMA ADMIN.
K800961 · FCE
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 21d
Cleared May 14, 1980
IMMUNOGLOBULIN E TEST KIT
K800995 · DGO
Calbiochem-Behring Corp.
Immunology · 19d
Cleared May 14, 1980
HDL REAGENT
K800996 · LBR
Gilford Diagnostics
Chemistry · 19d
Cleared May 14, 1980
IL SYSTEM 502 NA/K ANALYZER
K801007 · JGS
Instrumentation Laboratory CO
Chemistry · 16d
Cleared May 14, 1980
TRIGLYCERIDE REAGENT (COLOR)
K801012 · JGY
Gilford Diagnostics
Chemistry · 16d
Cleared May 14, 1980
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
K801015 · GIM
Kimble-Terumo, Inc.
Chemistry · 15d
Cleared May 14, 1980
IMMULON 1, #11-010-3350 & IMMULON 2 #--
K801018
Dynatech Laboratories, Inc.
Chemistry · 14d
Cleared May 14, 1980
ANATON
K801046 · DHN
Armkel, LLC
Immunology · 9d
Cleared May 14, 1980
ACCUDYNAMIC
K801048 · DRS
Sorensen Research
Cardiovascular · 9d
Cleared May 14, 1980
SUPRA SCOPE
K801050 · BZS
Warner-Lambert Co.
Anesthesiology · 9d
Cleared May 14, 1980
DISPOSABLE PATIENT CABLE MODEL 5807
K801064 · DSA
Daig Corp.
Cardiovascular · 8d
Cleared May 14, 1980
DELUXE HEAT WRAP/COLD WRAP
K801081 · IRT
The Gillette Company
Physical Medicine · 7d
Cleared May 14, 1980
EMPI MODEL 910S, TENS
K801112 · GZJ
Empi
Neurology · 2d
Cleared May 08, 1980
VITA LAMP, MODEL 0350
K800067 · KZF
Tensor Industries, Inc.
General Hospital · 118d
Cleared May 08, 1980
RMS 111F RESPIRATORY MONITORING SYSTEM
K800086 · BZK
The Perkin-Elmer Corp.
Anesthesiology · 115d
Cleared May 08, 1980
CLINIGUARD
K800527 · KMF
Clinipad Corp.
General & Plastic Surgery · 62d
Cleared May 08, 1980
PLASMA PRODUCTS CO., INTRA/ADMIN/SET-
K800637 · FPA
Plasma Products Co.
General Hospital · 45d
Cleared May 08, 1980
PLASMA PRODUCTS CO. NON-VENTED INTRA/SET
K800638 · FPA
Plasma Products Co.
General Hospital · 45d
Cleared May 08, 1980
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC
K800649 · CDT
Reagents Applications, Inc.
Chemistry · 45d
Cleared May 08, 1980
QUIK-TEMP
K800666 · KPP
Liquid Crystal Products, Inc.
Gastroenterology & Urology · 43d