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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142801–142824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1986
TENDERM TAPE
K863194
Lectec Corp.
General & Plastic Surgery · 42d
Cleared Sep 30, 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 27d
Cleared Sep 30, 1986
DRAPE STERICOVER
K863512 · KKX
Sterimed, Inc.
General Hospital · 21d
Cleared Sep 30, 1986
ELECTRONIC METAL LOCATOR MODEL MD-1
K863516
Advanced Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Sep 30, 1986
REUSABLE/DISPOSABLE AUTOPSY KNIFE SET
K863549 · EMF
Surgipath Medical Industries, Inc.
General & Plastic Surgery · 18d
Cleared Sep 30, 1986
XANTHINE/TYROSINE/CASEIN AGAR
K863572 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 18d
Cleared Sep 30, 1986
BIRD SEED AGAR
K863573 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 18d
Cleared Sep 30, 1986
STARCH AGAR W/BROM CRESOL PURPLE
K863599 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM
K863600 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
ONPG SOLUTION
K863601 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
BUFFERED GLYCEROL SALINE
K863602 · JSM
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 30, 1986
GI MOTILITY TEST MEDIUM W/TTC
K863603 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared Sep 29, 1986
HDL/CHOLESTEROL TEST SYSTEM
K861244 · LBS
Chrometrics Laboratories, Inc.
Chemistry · 180d
Cleared Sep 29, 1986
HEPARIN-COATED EXTRACORPOREAL CIRCUITS
K861641 · DTZ
American Bentley
Cardiovascular · 152d
Cleared Sep 29, 1986
COAGULATOR (8 CHANNEL)
K862047 · KQG
Med USA
Hematology · 123d
Cleared Sep 29, 1986
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
K862148 · JJO
Olympus Corp.
Chemistry · 117d
Cleared Sep 29, 1986
MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT
K862354 · LJP
Synbiotics Corp.
Microbiology · 101d
Cleared Sep 29, 1986
AMYLASE SR LIQUID STABLE REAGENT SET
K862733 · JFJ
Medical Analysis Systems, Inc.
Chemistry · 73d
Cleared Sep 29, 1986
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · GQG
Kallestad Laboratories, Inc.
Microbiology · 70d
Cleared Sep 29, 1986
ANGIOMED VAC-U-CUT BIOPSY NEEDLE
K862805 · GDM
Angiomed U.S., Inc.
General & Plastic Surgery · 69d
Cleared Sep 29, 1986
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840 · FJG
Gambro, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 29, 1986
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · DTN
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Sep 29, 1986
F-11 REFLECTOR / F-II STANDARD REFLECTOR
K863019 · EAZ
Sds Dental, Inc.
Dental · 52d
Cleared Sep 29, 1986
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 48d