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
75985–76008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2002
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123,...
K020204 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 21, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K020494 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 8d
Cleared Feb 20, 2002
ENRAF-NONIUS ENDOMED 182 SYSTEM
K003744 · GZJ
Henley Healthcare, Inc.
Neurology · 443d
Cleared Feb 20, 2002
SI ASCOPE
K011273 · PSN
Astron Clinica Limited
General & Plastic Surgery · 300d
Cleared Feb 20, 2002
MODIFICATION TO WARTNER WART REMOVAL SYSTEM
K011708 · GEH
Wartner Medical Products
General & Plastic Surgery · 261d
Cleared Feb 20, 2002
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
K013259 · HKX
Leica Microsystems, Inc. O.I.D.
Ophthalmic · 142d
Cleared Feb 20, 2002
DFINER UROLOGICAL CATHETER
K013360 · FGI
Neoseed Technology,Llc
Gastroenterology & Urology · 133d
Cleared Feb 20, 2002
BABYCOM
K013547 · KNG
Pmg Medica , Ltd.
Radiology · 119d
Cleared Feb 20, 2002
NEUROSENSOR
K013930 · GWM
Novus Monitoring, Ltd.
Neurology · 84d
Cleared Feb 20, 2002
UNIFIL BOND
K013997 · KLE
GC America, Inc.
Dental · 78d
Cleared Feb 20, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · LPN
Allergan, Inc.
Ophthalmic · 61d
Cleared Feb 20, 2002
SYNTHES CRANIAL PLATES
K020087 · JEY
Synthes (Usa)
Dental · 41d
Cleared Feb 20, 2002
VASOVIEW 5 HARVESTING CANNULA
K020143 · HET
Guidant Corporation, Cardiac Surgery
Obstetrics & Gynecology · 35d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 19, 2002
CRYSTAL MONITOR MODEL 16
K013863 · OMC
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared Feb 19, 2002
CLEARPLANE EASY OVULATION TEST
K013874 · CEP
Unipath , Ltd.
Chemistry · 90d
Cleared Feb 19, 2002
PRIME-DENT HEMA DESENSITIZER
K013970 · EBF
Prime Dental Manufacturing, Inc.
Dental · 78d
Cleared Feb 19, 2002
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
K014167 · NBW
Polymedica Pharmaceuticals, U.S.A.,...
Chemistry · 62d
Cleared Feb 19, 2002
MEDSURG EQUIPMENT COVERS
K014239 · MMP
International Medsurg Connection
General Hospital · 55d
Cleared Feb 19, 2002
JETPOLISHER
K014249 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
JETSTREAM
K014252 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF
Kamiya Biomedical Co.
Immunology · 53d
Cleared Feb 19, 2002
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · EKZ
Diagnostic Data, Inc.
Dental · 41d