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
79033–79056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K010628 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 52d
Cleared Apr 23, 2001
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
K010709 · MRD
Mentor Corp.
General & Plastic Surgery · 45d
Cleared Apr 23, 2001
TAKE ONE BITE MODIFIED
K010994 · ELW
Kerr Corp.
Dental · 20d
Cleared Apr 20, 2001
ORIGEN BLADDER HOLDER
K003145 · DWC
Origen Biomedical, Inc.
Cardiovascular · 192d
Cleared Apr 20, 2001
SOFTLASE - SURGICAL DIODE LASER SYSTEM
K003440 · GEX
Zap Lasers, Inc.
General & Plastic Surgery · 165d
Cleared Apr 20, 2001
RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
K003809 · DKZ
Rapid Diagnostics, Inc.
Toxicology · 133d
Cleared Apr 20, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · ETN
Uromed Corp.
Ear, Nose, Throat · 87d
Cleared Apr 20, 2001
CAVITY VARNISH
K010255 · LBH
Rite-Dent Manufacturing Corp.
Dental · 81d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · MMI
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314 · JIT
Dade Behring, Inc.
Chemistry · 77d
Cleared Apr 20, 2001
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042,...
K010341 · GWG
Medtronic PS Medical
Neurology · 74d
Cleared Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637 · LFL
Synergetics, Inc.
General & Plastic Surgery · 46d
Cleared Apr 20, 2001
SIMPLICITY SOFT QD EASY INFUSION SET
K010788 · FPA
Sterling Medivations, Inc.
General Hospital · 36d
Cleared Apr 20, 2001
SYNPLUG
K010840 · LZN
Isotis NV
Orthopedic · 30d
Cleared Apr 20, 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · DQY
NuMED, Inc.
Cardiovascular · 28d
Cleared Apr 20, 2001
BEAUTIFIL
K010914 · EBF
Shofu Dental Corp.
Dental · 24d
Cleared Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · DIS
Syva Co., Dade Behring, Inc.
Toxicology · 23d
Cleared Apr 20, 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · GXD
Stryker Instruments
Neurology · 18d
Cleared Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · LCD
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared Apr 20, 2001
SAFESTING AND SAFESTING HUB
K011003 · FPA
Diasol, Inc.
General Hospital · 16d
Cleared Apr 20, 2001
OPTIMA
K011053 · ITI
Medical Industries America, Inc.
Physical Medicine · 14d
Cleared Apr 19, 2001
DISPO-MED 7.6 LITER SHARPS CONTAINER
K003521 · FMI
Master Benefits, Inc.
General Hospital · 156d
Cleared Apr 19, 2001
BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)
K010890 · FMF
Becton, Dickinson and Co.
General Hospital · 24d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d