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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145849–145872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1985
CHURCHILL-H VENTED IV SET
K854437 · FPA
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Dec 05, 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · CHL
Nova Biomedical Corp.
Chemistry · 17d
Cleared Dec 04, 1985
CARDIAC COMMUNICATOR 2000
K852654 · DSI
Creative Medical, Inc.
Cardiovascular · 163d
Cleared Dec 04, 1985
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A
K852710 · DTB
Telectronics, Inc.
Cardiovascular · 161d
Cleared Dec 04, 1985
NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC
K852976
American Micro Scan
Microbiology · 142d
Cleared Dec 04, 1985
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA
K853294 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 110d
Cleared Dec 04, 1985
MEDTRONIC MODEL 5062
K853398 · DTB
Medtronic Vascular
Cardiovascular · 114d
Cleared Dec 04, 1985
ELECTROLYTE ANALYZER SERA-252
K853405 · CHL
Horiba Instruments, Inc.
Chemistry · 114d
Cleared Dec 04, 1985
LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08
K853517 · DTB
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
POLYFLEX IMPLANTABLE PACING LEAD-476-07
K853521 · DTB
Intermedics, Inc.
Cardiovascular · 104d
Cleared Dec 04, 1985
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
K853695 · GQG
Viromed Laboratories, Inc.
Microbiology · 91d
Cleared Dec 04, 1985
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
K853718 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 90d
Cleared Dec 04, 1985
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410
K853719 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 90d
Cleared Dec 04, 1985
EXPLORER
K853850 · DTB
Mansfield Scientific, Inc.
Cardiovascular · 79d
Cleared Dec 04, 1985
POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD
K854071 · DTB
Intermedics, Inc.
Cardiovascular · 61d
Cleared Dec 04, 1985
ARRHYTHMIA REVIEW STATION
K854136 · DXG
Marquette Electronics, Inc.
Cardiovascular · 55d
Cleared Dec 04, 1985
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
K854184 · KLB
Clinical Data, Inc.
Toxicology · 50d
Cleared Dec 04, 1985
PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD
K854220 · DTB
Pacesetter Systems
Cardiovascular · 47d
Cleared Dec 04, 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · DTL
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Dec 04, 1985
KONTRON DEFIBRILLATOR 7501
K854307 · LDD
Kontron Instruments, Inc.
Cardiovascular · 40d
Cleared Dec 04, 1985
ACS INDEFLATOR (MODIFICATION)
K854310 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Dec 04, 1985
HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS
K854376 · JPA
Hemotec, Inc.
Hematology · 35d
Cleared Dec 04, 1985
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
K854377 · JOX
Hemotec, Inc.
Hematology · 35d