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
78841–78864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · JEY
Bioplate, Inc.
Dental · 7d
Cleared May 11, 2001
BIOKNOTLESS ANCHOR
K002639 · GAM
Mitek Products
General & Plastic Surgery · 260d
Cleared May 11, 2001
CARDIAC FUNCTION LABORATORY
K003020 · DQO
Cd Leycom BV
Cardiovascular · 226d
Cleared May 11, 2001
BIOFIND
K003480 · GZO
Bio-Scan, Inc.
Neurology · 183d
Cleared May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · KRO
Plus Orthopedics
Orthopedic · 179d
Cleared May 11, 2001
SKINGARD POLYCOAT GLOVE
K004018 · LYY
Top Quality Mfg., Inc.
General Hospital · 135d
Cleared May 11, 2001
E-POWER
K010395 · ITI
Dalton Medical Corp.
Physical Medicine · 91d
Cleared May 11, 2001
R & D 4K RETIC
K010470 · JPK
R&D Systems, Inc.
Hematology · 80d
Cleared May 11, 2001
CG-900P FETAL/MATERNAL MONITOR
K010552 · HGM
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 74d
Cleared May 11, 2001
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K010803 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 56d
Cleared May 11, 2001
AMYSEAT TILT/RECLINE SEATING
K011006 · ITI
Amysystems
Physical Medicine · 37d
Cleared May 11, 2001
REGAL MOTOTRIZED 3 WHEELED VEHICLE
K011227 · ITI
Bruno Independent Living Aids, Inc.
Physical Medicine · 18d
Cleared May 10, 2001
CRP HS TEST SYSTEM
K003400 · DCN
Roche Diagnostics Corp.
Immunology · 190d
Cleared May 10, 2001
IMMUNETICS C6 LYME ELISA KIT
K003754 · LSR
Immunetics, Inc.
Microbiology · 156d
Cleared May 10, 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · DZE
Straumann USA
Dental · 99d
Cleared May 10, 2001
THE MAESTRO SYSTEM
K010458 · DZE
BioHorizons Implant Systems, Inc.
Dental · 83d
Cleared May 10, 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · JIS
Beckman Coulter, Inc.
Immunology · 63d
Cleared May 10, 2001
BRIDGE III RECEIVER
K010794 · DXH
Meridian Medical Technologies , Ltd.
Cardiovascular · 55d
Cleared May 10, 2001
DENTO-PREP PARTICLE MICROBLASTER
K010816 · KOJ
Ronvig A/S
Dental · 52d
Cleared May 10, 2001
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K010879 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 48d
Cleared May 10, 2001
RD-3008
K011036 · EJT
Heraeus Kulzer, Inc.
Dental · 35d
Cleared May 10, 2001
MANDREL GUIDEWIRE ASSEMBLY
K011084 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
K011163 · JXN
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · KXS
Syva Co., Dade Behring, Inc.
Toxicology · 24d