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
156073–156096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1983
STANDARD METHOD BROTH
K833217 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 38d
Cleared Oct 27, 1983
YEAST BEEF AGAR-ANTIBIOTIC MED.4
K833218 · LKA
Acumedia Manufacturers, Inc.
Microbiology · 38d
Cleared Oct 27, 1983
STAPHYLOCOCCUS AGAR 10
K833219 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 38d
Cleared Oct 27, 1983
LOWENSTEIN-JENSEN MEDIUM BASE
K833220 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 38d
Cleared Oct 27, 1983
SONICAID MODEL D206E AIR EMBOLI-DETECT
K833227 · LBA
Sonicaid, Inc.
Toxicology · 72d
Cleared Oct 26, 1983
LME HEART-RATE MONITOR
K832016 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT - VARIOUS
K832024 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/
K832026 · DRT
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED STANDARD SMS 104
K832041 · DRT
Litton Medical Electronics
Cardiovascular · 124d
Cleared Oct 20, 1983
SILICONE-SILVER PENILE PROSTHESIS-ESK
K830667 · FTQ
Dacomed Corp.
Gastroenterology & Urology · 230d
Cleared Oct 20, 1983
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A
K831458 · DWB
Electromedics, Inc.
Cardiovascular · 167d
Cleared Oct 20, 1983
TEMP. CARDIAC PACING WIRE TME 60/61/65
K831695 · LDF
Oscor, Inc.
Cardiovascular · 148d
Cleared Oct 20, 1983
LEAD INTRODUCER SETS-EB-S8 & EB-S12
K831751 · DYB
Oscor, Inc.
Cardiovascular · 141d
Cleared Oct 20, 1983
MULTIPOLAR TEMPORARY CARDIAC
K831804 · LDF
Oscor, Inc.
Cardiovascular · 139d
Cleared Oct 20, 1983
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · DYG
C.R. Bard, Inc.
Cardiovascular · 133d
Cleared Oct 20, 1983
BLOOD OXYGENATOR 5070
K831894 · DTZ
Shiley, Inc.
Cardiovascular · 128d
Cleared Oct 20, 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997 · DTB
Oscor, Inc.
Cardiovascular · 121d
Cleared Oct 20, 1983
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K832043 · FAE
Medical Engineering Corp.
Gastroenterology & Urology · 118d
Cleared Oct 20, 1983
ATAC 4700 HEMATOLOGY CELL COUNTER
K832116 · GIF
Turpen Laboratory Systems, Inc.
Hematology · 112d
Cleared Oct 20, 1983
ASPIRATOR
K832274 · BTA
Wells Johnson Co.
General & Plastic Surgery · 100d
Cleared Oct 20, 1983
INTRAMEDULLARY BONE PLUG
K832328 · JDS
Kirschner Medical Corp.
Orthopedic · 97d
Cleared Oct 20, 1983
HOLTA-MED RECORDER
K832395 · DSH
Holta-Med
Cardiovascular · 93d
Cleared Oct 20, 1983
HYPOTHERMIC MYCARDIAL PROTECTION DEV
K832417 · DTR
3M Health Care, Sarns
Cardiovascular · 91d
Cleared Oct 20, 1983
PLATELET AGGREGATION REAGENT SET
K832428 · GHR
Helena Laboratories
Hematology · 90d