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

Filters: Cleared only ×
176,076 results
167857–167880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1980
ULTRASONIC FLOWMETER
K800087 · BXP
The Perkin-Elmer Corp.
Anesthesiology · 65d
Cleared Mar 19, 1980
HEPCON/SYSTEM RC-10
K800161 · JOX
Hemotec, Inc.
Hematology · 55d
Cleared Mar 19, 1980
VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
K800180 · GIF
Laboratory Products, Inc.
Hematology · 50d
Cleared Mar 19, 1980
RIA PHASE T4
K800203 · CDX
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
RIA PHASE TBG
K800204 · CEE
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
RIA PHASE DIGOXIN
K800205 · DPO
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
BEHIND EAR HEARING AID MODEL E24C1
K800244 · ESD
Oticon Corp.
Ear, Nose, Throat · 43d
Cleared Mar 19, 1980
CEPH LACTAM DISK
K800287 · JSF
Remel Co.
Microbiology · 37d
Cleared Mar 19, 1980
POWER PACK
K800314 · KIJ
Black & Decker(Tm)
Orthopedic · 36d
Cleared Mar 19, 1980
DUAL MPC CHARGER
K800315 · KIJ
Black & Decker(Tm)
Orthopedic · 36d
Cleared Mar 19, 1980
CARDIOPLEGIA DELIVERY SYSTEM
K800377 · DTR
3M Health Care, Sarns
Cardiovascular · 27d
Cleared Mar 19, 1980
REFRIG. CENTRIFUGE (DRUCKER MODEL)
K800381 · JQC
Coulter Electronics, Inc.
Chemistry · 26d
Cleared Mar 19, 1980
SMAC SYSTEM, T4 METHOD
K800384 · KLI
Technicon Instruments Corp.
Chemistry · 26d
Cleared Mar 19, 1980
ANALYTE T4-THYROXINE
K800385 · CDX
Technicon Instruments Corp.
Chemistry · 26d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST
K800426 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT
K800427 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/CYSTEINE AND
K800428 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%
K800429 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
K800436 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 21d
Cleared Mar 19, 1980
PERCUTANEOUS INTRODUCER SET
K800462 · DRE
Medical Components, Inc.
Cardiovascular · 19d
Cleared Mar 19, 1980
STIM-EX 201
K800486 · IPF
Th Charters, Inc.
Physical Medicine · 15d
Cleared Mar 19, 1980
PHENCYCLIDINE DIRECT BLOOD RIA KIT
K800514 · LCL
Immunalysis Corporation
Toxicology · 14d
Cleared Mar 19, 1980
DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.
K800516 · KIE
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 14d
Cleared Mar 18, 1980
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.
K800456 · BTL
Khi, Inc.
Anesthesiology · 18d