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
70273–70296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2003
MINERVA 58 ALLOY
K032318 · EJT
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
CERA R PLUS ALLOY
K032319 · EJT
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
CERA F ALLOY
K032321 · EJT
Dentsply International
Dental · 64d
Cleared Sep 30, 2003
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · GXQ
Integra Lifesciences Corp.
Neurology · 28d
Cleared Sep 30, 2003
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
K032701 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 28d
Cleared Sep 30, 2003
ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM
K032875 · IYO
Aloka Co. Ltd USA
Radiology · 15d
Cleared Sep 29, 2003
KSEA MEDI PACK
K022490 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 427d
Cleared Sep 29, 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 376d
Cleared Sep 29, 2003
AML HAIRCHECK-DT (COCAINE)
K023626 · DIO
Quest Diagnostics, Inc.
Toxicology · 335d
Cleared Sep 29, 2003
DRESSSKIN
K023778 · KGN
Tei Biosciences, Inc.
General & Plastic Surgery · 321d
Cleared Sep 29, 2003
ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR
K030003 · CIG
Elan Diagnostics
Chemistry · 270d
Cleared Sep 29, 2003
TORAYSULFONE DIALYZER, BS-L SERIES
K030050 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 266d
Cleared Sep 29, 2003
PARAPAC 200D TRANSPORT, MODEL V200D
K030803 · BTL
Pneupac , Ltd.
Anesthesiology · 200d
Cleared Sep 29, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
K031031 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 181d
Cleared Sep 29, 2003
TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004
K031225 · FTL
Gfe Medizintechnik GmbH
General & Plastic Surgery · 165d
Cleared Sep 29, 2003
INTRALASE FS LASER
K031960 · GEX
Intra Lase Corp.
General & Plastic Surgery · 96d
Cleared Sep 29, 2003
ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00,...
K031974 · HIH
Asap Endoscopic Products GmbH
Obstetrics & Gynecology · 95d
Cleared Sep 29, 2003
ENVISION
K032042 · DYH
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · MID
The Binding Site, Ltd.
Immunology · 70d
Cleared Sep 29, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE...
K032275 · LON
Becton, Dickinson & CO
Microbiology · 68d
Cleared Sep 26, 2003
MAKY 21.1 DIALYZER REPROCESSING SYSTEM
K024076 · LIF
Hdc Maquinolas, LLC
Gastroenterology & Urology · 290d
Cleared Sep 26, 2003
ATAC TOTAL BILIRUBIN REAGENT
K030014 · CIG
Elan Diagnostics
Chemistry · 267d
Cleared Sep 26, 2003
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
K031308 · DBM
Rhigene, Inc.
Immunology · 155d