FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142201–142224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1986
ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT
K863015
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
DENTATUS L SET
K863016 · KLC
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
CM-II, CM-I WATER UNIT
K863021 · EIA
Sds Dental, Inc.
Dental · 54d
Cleared Oct 01, 1986
IMMUNO BIOTECH MUGWART ALLERGEN DISC
K863123 · DHB
Immuno Nuclear Corp.
Immunology · 48d
Cleared Oct 01, 1986
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
K863425 · CDW
American Research Products Co.
Chemistry · 27d
Cleared Oct 01, 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487 · DBF
Bio-Rad
Immunology · 22d
Cleared Sep 30, 1986
SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2
K854533
Madsen Electronics (Canada) , Ltd.
Neurology · 321d
Cleared Sep 30, 1986
COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
K862814 · LQP
Institute Virion , Ltd.
Microbiology · 68d
Cleared Sep 30, 1986
SHARPOINT STAINLESS STEEL SUTURE
K863034 · GAO
Chathamborough Research Group, Inc.
General & Plastic Surgery · 50d
Cleared Sep 30, 1986
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · LQL
American Micro Scan
Microbiology · 49d
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