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
114361–114384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1993
MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR
K925411 · DSI
Accucore, Inc.
Cardiovascular · 122d
Cleared Feb 25, 1993
SERIES 1500 DEFIBRILLATOR, MODIFICATION
K926172 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 86d
Cleared Feb 25, 1993
TRIODOTHYRONINE (TC) COATED TUBE RIA
K926345 · CDP
Monobind
Chemistry · 70d
Cleared Feb 25, 1993
COBAS-FP TDM CONTROLS
K930269 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Feb 24, 1993
AFFINITY BED MODEL 3600 SERIES
K915779 · KNC
Hill-Rom, Inc.
Obstetrics & Gynecology · 428d
Cleared Feb 23, 1993
TECHMEDICA CAD/CAM CUSTOM HIP
K911058 · JDI
Techmedica, Inc.
Orthopedic · 718d
Cleared Feb 23, 1993
.25' ULTRA-SELECT GUIDEWIRE
K922060 · DQX
Microvena Corp.
Cardiovascular · 295d
Cleared Feb 23, 1993
PNEUMATHERM
K922089 · IRT
National Pain Institute
Physical Medicine · 295d
Cleared Feb 23, 1993
SONGER CABLE SYSTEM
K922952 · JDQ
Pioneer Surgical Technology
Orthopedic · 250d
Cleared Feb 23, 1993
THERABEAM INFRARED HEAT LAMP
K923254 · ILY
Strategic Alliances Corp.
Physical Medicine · 236d
Cleared Feb 23, 1993
EXPRESSO CARTRIDGE
K923316 · JQP
Bio-Rad Laboratories, Inc.
Chemistry · 231d
Cleared Feb 23, 1993
9293/1 INTERFACE MODULE
K923418 · DQA
S & W Medico Teknik
Anesthesiology · 225d
Cleared Feb 23, 1993
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K923420 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 225d
Cleared Feb 23, 1993
COMPEL SURGICAL DRAPES
K923811 · KKX
Standard Textile Co., Inc.
General Hospital · 209d
Cleared Feb 23, 1993
DEVILBISS MODEL 5650 PULMO-AIDE
K923888 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 203d
Cleared Feb 23, 1993
CANCER ANTIGEN CONTROL
K924061 · JJY
Polymedco, Inc.
Immunology · 195d
Cleared Feb 23, 1993
STAT PROFILE 9 ANALYZER
K924497 · CHL
Nova Biomedical Corp.
Chemistry · 172d
Cleared Feb 23, 1993
ENDOSTATS, MICROSTATS, ACCUSTATS
K924644 · GEX
Laserscope
General & Plastic Surgery · 162d
Cleared Feb 23, 1993
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · CFF
The Binding Site, Ltd.
Immunology · 153d
Cleared Feb 23, 1993
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769 · CFF
The Binding Site, Ltd.
Immunology · 153d
Cleared Feb 23, 1993
PHOTOTHERAPY TIMER
K924969 · FTC
National Biological Corp.
General & Plastic Surgery · 146d
Cleared Feb 23, 1993
SYSTEMATE PLUS CALIBRATOR
K925101 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 138d
Cleared Feb 23, 1993
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
K925183 · KTN
Princeton Biomedix
Immunology · 132d
Cleared Feb 23, 1993
SYMBIOSIS HEMOSTATIC WAND
K925410 · GCJ
Symbiosis Corp.
General & Plastic Surgery · 120d