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
130417–130440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1989
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
K892915 · KDQ
Deknatel, Inc.
General Hospital · 62d
Cleared Jun 21, 1989
DELTA (TM) ROBOTIC PIPETTOR
K893031 · JQW
Diagnostic Products Corp.
Chemistry · 58d
Cleared Jun 21, 1989
SHARPLAN 1075 CO2 LASER
K893206 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 56d
Cleared Jun 21, 1989
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
K893255 · DYH
American Orthodontics
Dental · 54d
Cleared Jun 21, 1989
LATEX SURGICAL GLOVES
K893340 · KGO
Kenmark Industrial Co., Ltd.
General Hospital · 57d
Cleared Jun 21, 1989
SLT CONTACT LASER SYSTEM
K893701 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 34d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO B REAGENT
K893884 · MSJ
Catachem, Inc.
Immunology · 22d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO A-I REAGENT
K893885 · DEL
Catachem, Inc.
Chemistry · 22d
Cleared Jun 20, 1989
PACEMAKER LEAD ADAPTER
K890018 · DTB
Ela Medical, Inc.
Cardiovascular · 168d
Cleared Jun 20, 1989
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
K890047 · LYK
Vascucare, Inc.
Cardiovascular · 166d
Cleared Jun 20, 1989
USCI GREY/BLACK GUIDE WIRE
K890505 · DQX
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Jun 20, 1989
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639 · LJN
Diagnostic Technology, Inc.
Microbiology · 132d
Cleared Jun 20, 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · LDF
Daig Corp.
Cardiovascular · 123d
Cleared Jun 20, 1989
GUIDE WIRE INTRODUCER
K890807 · DQX
Datascope Corp.
Cardiovascular · 124d
Cleared Jun 20, 1989
HSV-CHECK(TM) TEST KIT
K890819 · HIS
Diagnostic Technology, Inc.
Microbiology · 123d
Cleared Jun 20, 1989
IL1400, BGELECTROLYTE ANALYZER
K890827 · CHL
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Jun 20, 1989
PERIFLUX PF3
K890828 · DPW
Perimed, Inc.
Cardiovascular · 119d
Cleared Jun 20, 1989
SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE
K890926 · FMI
Meadox Surgimed, Inc.
General Hospital · 116d
Cleared Jun 20, 1989
HSV-1 ELISA TEST SYSTEM
K891162 · GQL
Zeus Scientific, Inc.
Microbiology · 106d
Cleared Jun 20, 1989
DR. VOLKNER'S LAMELLAR TURNING BED(TM)
K891457 · FNM
James Consolidated, Inc.
General Hospital · 98d
Cleared Jun 20, 1989
EBNA-CHECK(TM) TEST KIT
K891542 · LLM
Diagnostic Technology, Inc.
Microbiology · 95d
Cleared Jun 20, 1989
HSV-2 ELISA TEST SYSTEM
K891782 · GQL
Zeus Scientific, Inc.
Microbiology · 88d
Cleared Jun 20, 1989
AMRESCO PRODUCT NUMBER 7426
K891923 · CFR
American Research Products Co.
Chemistry · 85d
Cleared Jun 20, 1989
SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9
K892005 · MKJ
Physio-Control Corp.
Cardiovascular · 84d