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
78457–78480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2001
NEURO-TRAIN III (3)
K003433 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 221d
Cleared Jun 15, 2001
ACTI-ICP MONITORING SYSTEM
K003905 · GWM
Innerspace, Inc.
Neurology · 178d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · DQY
Cordis Corp.
Cardiovascular · 178d
Cleared Jun 15, 2001
NTERO NOMAD SYSTEM
K010815 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 88d
Cleared Jun 15, 2001
MX8000 V5.0 CT SYSTEM
K010817 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Jun 15, 2001
HANDMASTER
K010837 · GZI
Neuromusclar Electrical Stimulation...
Neurology · 87d
Cleared Jun 15, 2001
MALE NATURAL RUBBER LATEX CONDOM
K010919 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 80d
Cleared Jun 15, 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · OCL
Endocare, Inc.
Cardiovascular · 71d
Cleared Jun 15, 2001
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
K011183 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 58d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262 · HWC
New Deal, S.A.
Orthopedic · 51d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
K011534 · OLW
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · KPS
Digirad Corp.
Radiology · 25d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL...
K011622 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · JDI
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 14, 2001
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
K002543 · CAF
San UP S.A.
Anesthesiology · 302d
Cleared Jun 14, 2001
PULSECO HEMODYNAMIC MONITOR CM71
K010049 · DXG
Lidco, Ltd.
Cardiovascular · 160d
Cleared Jun 14, 2001
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
K010055 · DRE
Cook Vascular, Inc.
Cardiovascular · 157d
Cleared Jun 14, 2001
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
K010093 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 154d
Cleared Jun 14, 2001
PORTABLE INSTENSIVE CARE UNIT
K010207 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · JIX
Dade Behring, Inc.
Chemistry · 70d
Cleared Jun 14, 2001
BCI 3403 SLEEP SCREENING PULSE OXIMETER
K011156 · DQA
Bci, Inc.
Anesthesiology · 59d
Cleared Jun 14, 2001
GILB, MODEL 8010
K011200 · EMA
3M Company
Dental · 56d