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
84001–84024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 09, 1999
MENISCUS ARROW, MODELS 531110, 531113, 531116
K993453 · MAI
Bionx Implants, Ltd.
Orthopedic · 27d
Cleared Nov 09, 1999
WAKO L-TYPE TRIGLYCERIDE TEST
K993466 · CDT
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared Nov 09, 1999
WAKO L-TYPE UA F TEST
K993469 · KNK
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared Nov 09, 1999
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K993712 · FMZ
Ohmeda Medical
General Hospital · 6d
Cleared Nov 08, 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326 · MNI
Scien'Tx USA, Inc.
Orthopedic · 203d
Cleared Nov 08, 1999
TITANIUM HARTSHILL SYSTEM
K991662 · KWP
Surgicraft , Ltd.
Orthopedic · 178d
Cleared Nov 08, 1999
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
K992621 · HRX
Advanced Diagnostics & Interventions
Orthopedic · 95d
Cleared Nov 08, 1999
HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
K992674 · MHX
Hewlett-Packard GmbH
Cardiovascular · 90d
Cleared Nov 08, 1999
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT...
K992702 · FMW
Allergy Direct
General Hospital · 88d