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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119785–119808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1991
BACTIDROP (TM) NITRATE B
K913010 · JTO
Remel Co.
Microbiology · 73d
Cleared Sep 19, 1991
BACTIDROP(TM) NITRATE A
K913011 · JTO
Remel Co.
Microbiology · 73d
Cleared Sep 19, 1991
SIME TRUFEEL
K913048 · LYY
Sime Health, Ltd.
General Hospital · 72d
Cleared Sep 19, 1991
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · KLS
Syva Co.
Toxicology · 66d
Cleared Sep 19, 1991
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
K913147 · IXR
Shimadzu Medical Systems
Radiology · 65d
Cleared Sep 19, 1991
BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE
K913243 · IXG
Bennett X-Ray Corp.
Radiology · 59d
Cleared Sep 19, 1991
VISTA HPQ SYSTEM
K913534 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 41d
Cleared Sep 19, 1991
CHEM-CHEX
K913687 · JJY
Streck Laboratories, Inc.
Chemistry · 31d
Cleared Sep 19, 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Sep 19, 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · DJG
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 19, 1991
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
K913867 · KLN
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Sep 18, 1991
HIGH SPEED MAGNETIC STIMULATOR
K905059 · GWF
Cadwell Laboratories, Inc.
Neurology · 314d
Cleared Sep 18, 1991
UTAH ESSU
K905263 · HGI
Utah Medical Products, Inc.
Obstetrics & Gynecology · 299d
Cleared Sep 18, 1991
PRO-GUIDE
K911747 · DQY
American Interventional Technology
Cardiovascular · 153d
Cleared Sep 18, 1991
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
K911912 · KHQ
Serono-Baker Diagnostics, Inc.
Chemistry · 141d
Cleared Sep 18, 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235 · DTB
Intermedics, Inc.
Cardiovascular · 127d
Cleared Sep 18, 1991
LEMAITRE-BOOKWALTER VESSEL DEVICES
K912548 · DWP
Vascutech, Inc.
Cardiovascular · 100d
Cleared Sep 18, 1991
ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS
K912614 · GEI
Andrew Surgical
General & Plastic Surgery · 98d
Cleared Sep 18, 1991
PLASTIC ATTACHABLE DUAL PORT
K912702 · LJT
Davol, Inc.
General Hospital · 91d
Cleared Sep 18, 1991
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS)
K912793 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 85d
Cleared Sep 18, 1991
BACTIDROP(TM) DESOXYCHOLATE (10%)
K913001 · JTO
Remel Co.
Microbiology · 72d
Cleared Sep 18, 1991
BACTIDROP(TM) SPOT INDOLE
K913004 · JTO
Remel Co.
Microbiology · 72d
Cleared Sep 18, 1991
BACTIDROP(TM) INDOLE (KOVACS)
K913009 · JTO
Remel Co.
Microbiology · 72d