FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79345–79368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2001
EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
K010197 · FPA
Exelint International, Co.
General Hospital · 112d
Cleared May 14, 2001
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001
K010436 · DXH
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 90d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared May 14, 2001
LIFELINES TRACKIT
K010460 · OLV
Lifelines , Ltd.
Neurology · 87d
Cleared May 14, 2001
DENSTAT
K010465 · GEI
Elmed, Inc.
General & Plastic Surgery · 87d
Cleared May 14, 2001
MAGNUM FLOW IRRIGATION SYSTEM
K010519 · GCJ
Scion Valley, Inc.
General & Plastic Surgery · 81d
Cleared May 14, 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · GAT
Arthrex, Inc.
General & Plastic Surgery · 69d
Cleared May 14, 2001
MODIFICATION TO SOLO
K011107 · INI
Ranger All Season Corp.
Physical Medicine · 28d
Cleared May 14, 2001
MODIFICATION TO IMPLANTABLE CLIP
K011236 · FZP
Applied Medical Resources Corp.
General & Plastic Surgery · 21d
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