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
76801–76824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2002
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
K011185 · DJC
Psychemedics Corp.
Toxicology · 281d
Cleared Jan 24, 2002
MULTI-SNARE SET
K011783 · DXE
Pfm Produkte Fur Die Medizin AG
Cardiovascular · 231d
Cleared Jan 24, 2002
EPS320 CARDIAC STIMULATOR
K011826 · JOQ
Micropace Pty, Ltd.
Cardiovascular · 227d
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 171d
Cleared Jan 24, 2002
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
K012749 · DQO
Biocardia, Inc.
Cardiovascular · 161d
Cleared Jan 24, 2002
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
K013120 · GZB
Medamicus, Inc.
Neurology · 128d
Cleared Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
K013636 · LNH
GE Medical Systems
Radiology · 80d
Cleared Jan 24, 2002
COALESCENT SURGICAL U-CLIP
K013664 · NCA
Coalescent Surgical
General & Plastic Surgery · 79d
Cleared Jan 24, 2002
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674 · EBG
Dmg USA, Inc.
Dental · 78d
Cleared Jan 24, 2002
SAFE
K013773 · HIS
Ssn Medical Products Sdn. Bhd.
Obstetrics & Gynecology · 72d
Cleared Jan 24, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K013899 · CDD
Ortho-Clinical Diagnostics
Toxicology · 62d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · KXK
Cp Medical
Radiology · 52d
Cleared Jan 24, 2002
HEMOCHRON JR. CITRATE APTT CUVETTE
K014008 · GFO
Itc, Inc.
Hematology · 50d
Cleared Jan 24, 2002
CAPTIAM SYPHILIS-G ASSAY
K014233 · LIP
Trinity Biotech, Plc
Microbiology · 29d
Cleared Jan 24, 2002
DELSONIC 2000
K014238 · ELC
Deldent , Ltd.
Dental · 29d
Cleared Jan 23, 2002
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
K010923 · MHX
Siemens Elema AB
Cardiovascular · 302d
Cleared Jan 23, 2002
VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
K011625 · DXN
Vasocor, Inc.
Cardiovascular · 243d
Cleared Jan 23, 2002
EXEL COMFORTPOINT INSULIN PEN NEEDLE
K011757 · FMI
Exelint Intl. Co.
General Hospital · 231d
Cleared Jan 23, 2002
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
K011967 · FOZ
Bd
General Hospital · 212d
Cleared Jan 23, 2002
INTRAORAL LENS OPTION TO SPECTROSHADE
K012744 · EIA
Mht Optic Research AG
Dental · 160d
Cleared Jan 23, 2002
PORTABLE INTENSIVE CARE UNIT
K012766 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 159d
Cleared Jan 23, 2002
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO...
K013303 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 111d
Cleared Jan 23, 2002
SCI-PHARM POST SECURE
K013555 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 90d
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · KWQ
Blackstone Medical, Inc.
Orthopedic · 90d