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
77569–77592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2001
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
K013255 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 40d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 07, 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382 · MQP
Depuyacromed
Orthopedic · 26d
Cleared Nov 07, 2001
GEMINI IMAGING SYSTEM
K013521 · JAK
Adac Laboratories
Radiology · 15d
Cleared Nov 07, 2001
SOMATOM P30 CT SYSTEMS
K013522 · JAK
Siemens Medical Systems, Inc.
Radiology · 15d
Cleared Nov 07, 2001
QWIKSIM VIRTUAL SIMULATION SYSTEM
K013531 · KPQ
Impac Medical Systems, Inc.
Radiology · 15d
Cleared Nov 06, 2001
WATCH-PAT 100
K010739 · MNR
Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology · 239d
Cleared Nov 06, 2001
PSYCHEMEDICS RIA COCAINE ASSAY
K010868 · KLN
Psychemedics Corp.
Toxicology · 228d
Cleared Nov 06, 2001
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 201d
Cleared Nov 06, 2001
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
K011861 · MOD
Cardiopulmonary Corp.
Anesthesiology · 145d
Cleared Nov 06, 2001
PF 5050 PRESSURE UNIT, MODEL PF 5050
K011899 · DPW
Perimed AB
Cardiovascular · 141d
Cleared Nov 06, 2001
SURESET INFUSION SET, MODEL 8023
K012429 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 98d
Cleared Nov 06, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
K012617 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Nov 06, 2001
SICKLE-CHEX
K013316 · GHM
Streck Laboratories, Inc.
Hematology · 33d
Cleared Nov 06, 2001
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 05, 2001
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
K002937 · LRT
Albert Browne , Ltd.
General Hospital · 410d
Cleared Nov 05, 2001
EVERSTICK
K011788 · EBI
Stick Tech , Ltd.
Dental · 150d
Cleared Nov 05, 2001
EVERSTICKNET
K011799 · EBI
Stick Tech , Ltd.
Dental · 150d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · DKZ
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Nov 05, 2001
ARAMIS DERMATLOGIC LASER
K012545 · GEX
Lumedics, Ltd.
General & Plastic Surgery · 90d
Cleared Nov 05, 2001
SCITON IMAGE HAIR REMOVAL LASER
K012552 · GEX
Sciton, Inc
General & Plastic Surgery · 89d
Cleared Nov 05, 2001
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
K012794 · EBF
Prime Dental Manufacturing, Inc.
Dental · 76d
Cleared Nov 05, 2001
THE V BAG, CATALOG NUMBER VB1800
K012942 · DTN
Circulatory Technology, Inc.
Cardiovascular · 66d
Cleared Nov 02, 2001
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439 · DSB
Cardiodynamics International Corp.
Cardiovascular · 176d