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
80785–80808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2000
TUTOPATCH
K991296 · FTM
Tutogen Medical U.S., Inc.
General & Plastic Surgery · 540d
Cleared Oct 05, 2000
TDK HANDPIECES
K000848 · EFB
Orasystems
Dental · 204d
Cleared Oct 05, 2000
SPIROL EPIDURAL CATHETER
K000886 · BSO
Abbott Laboratories
Anesthesiology · 199d
Cleared Oct 05, 2000
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
K001387 · CGA
I-Stat Corp.
Chemistry · 156d
Cleared Oct 05, 2000
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
K001603 · KLI
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
K001606 · JLW
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
K001607 · CDP
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
ASCEND SPINAL FIXATION SYSTEM
K002069 · KWP
Spinal Innovations, LLC
Orthopedic · 90d
Cleared Oct 05, 2000
CATHCOR DESKTOP
K002137 · DQK
Siemens Elema AB
Cardiovascular · 83d
Cleared Oct 05, 2000
REFACTO LABORATORY STANDARD
K002350 · GGP
The Genetics Institute
Hematology · 64d
Cleared Oct 05, 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 55d
Cleared Oct 05, 2000
XIA SPINE SYSTEM
K002505 · KWP
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Oct 05, 2000
RANDOX MICROALBUMIN
K002674 · DDZ
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Oct 05, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002751 · DQA
Masimo Corp.
Anesthesiology · 30d
Cleared Oct 05, 2000
ELECSYS DHEA-S CALSET
K002760 · JIS
Roche Diagnostics Corp.
Chemistry · 30d
Cleared Oct 05, 2000
VACUETTE WITH PPACK
K002777 · JKA
Greiner Vacuette North America, Inc.
Chemistry · 29d
Cleared Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
K002799 · CFF
Beckman Coulter, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Dade Behring, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
K002850 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 22d
Cleared Oct 05, 2000
ELS CANNULA (KIT), MODEL M1210-88,M1510-88
K002857 · DWF
Jostra AG
Cardiovascular · 22d
Cleared Oct 05, 2000
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · JEY
Bioplate, Inc.
Dental · 20d
Cleared Oct 04, 2000
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
K001125 · NCE
Geuder GmbH
Ophthalmic · 180d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · LYR
bioMerieux, Inc.
Microbiology · 147d