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
84505–84528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1999
LIGHT-CORE
K993488 · EBF
Bisco, Inc.
Dental · 26d
Cleared Nov 10, 1999
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583 · ETA
Stryker Corp.
Ear, Nose, Throat · 19d
Cleared Nov 10, 1999
SITE-RITE 3 ULTRASOUND SYSTEM
K993624 · IYO
Dymax Corp
Radiology · 15d
Cleared Nov 09, 1999
TED 60T OXYGEN ANALYZER
K990457 · CCL
Teledyne Electronic Technologies
Anesthesiology · 270d
Cleared Nov 09, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · GQN
Light Diagnostics
Microbiology · 160d
Cleared Nov 09, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907 · CZW
Bayer Corp.
Immunology · 155d
Cleared Nov 09, 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136 · CIT
Bayer Corp.
Chemistry · 138d
Cleared Nov 09, 1999
1818 TENS UNIT
K992709 · GZJ
138 Medical Supplies, Inc.
Neurology · 90d
Cleared Nov 09, 1999
EBT ULTRAFAST CT SCANNER SYSTEM
K992740 · JAK
Imatron, Inc.
Radiology · 85d
Cleared Nov 09, 1999
LYPHOCHEK ANEMIA CONTROL, MODEL 500
K992741 · JJY
Bio-Rad
Immunology · 85d
Cleared Nov 09, 1999
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
K992746 · LNH
Ge Medical Systems, Inc.
Radiology · 85d
Cleared Nov 09, 1999
STINGRAY DR, MODEL 1
K992794 · MQB
Infimed, Inc.
Radiology · 82d
Cleared Nov 09, 1999
SL990, SL980, SL950
K992836 · HJO
Cso
Ophthalmic · 78d
Cleared Nov 09, 1999
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
K992875 · GKZ
Sysmex Corp.
Hematology · 75d
Cleared Nov 09, 1999
ECUSIT COMPOSITE REPAIR
K992879 · KLE
Dmg Hamburg
Dental · 75d
Cleared Nov 09, 1999
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
K992886 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 75d
Cleared Nov 09, 1999
OSTEOMARK NTX POC
K992997 · JMM
Metrika, Inc.
Chemistry · 63d
Cleared Nov 09, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
K993022 · DLJ
Beckman Coulter, Inc.
Toxicology · 61d
Cleared Nov 09, 1999
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K993050 · LZA
Omnigrace , Ltd.
General Hospital · 60d
Cleared Nov 09, 1999
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
K993161 · JTW
Copan Diagnostics, Inc.
Microbiology · 48d
Cleared Nov 09, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174 · GKP
Dade Behring, Inc.
Hematology · 48d
Cleared Nov 09, 1999
WAKO BILIRUBIN CALIBRATOR
K993219 · JIS
Wako Chemicals USA, Inc.
Chemistry · 43d
Cleared Nov 09, 1999
K-ASSAY IGG
K993281 · DEW
Kamiya Biomedical Co.
Immunology · 40d
Cleared Nov 09, 1999
CARBOCEM ZINC POLYCARBOXYLATE CEMENT
K993324 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 36d