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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163105–163128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1981
AQUACADE
K811524 · LHC
Respiratory Care, Inc.
General Hospital · 33d
Cleared Jul 01, 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539 · DTB
Cordis Corp.
Cardiovascular · 30d
Cleared Jul 01, 1981
DENTAL FLOSS HOLDER
K811555 · JES
Sewon Industry
Dental · 29d
Cleared Jul 01, 1981
DAHLBERG MODEL AP HEARING AID
K811578 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jul 01, 1981
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG
K811592 · CGA
Amresco, Inc.
Chemistry · 23d
Cleared Jul 01, 1981
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
K811626 · DQC
Honeywell, Inc.
Cardiovascular · 22d
Cleared Jul 01, 1981
KINEMATIC ROTATING HINGE TOTAL KNEE PR.
K811630 · LGE
Howmedica Corp.
Orthopedic · 22d
Cleared Jul 01, 1981
MYELOSTAT DORSAL CORD STIMULATOR
K811655 · GZB
Medtronic Vascular
Neurology · 20d
Cleared Jul 01, 1981
P.D. CRADLE
K811657
Lung Care, Inc.
Physical Medicine · 20d
Cleared Jul 01, 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · EBF
Kulzer, Inc.
Dental · 16d
Cleared Jul 01, 1981
URIC ACID TEST
K811687 · KNK
King Diagnostics, Inc.
Chemistry · 16d
Cleared Jul 01, 1981
CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT
K811694 · CKA
Baker Instructions Corp.
Chemistry · 16d
Cleared Jul 01, 1981
HELENA FETAL-TEK 200 MARKER
K811695 · JJY
Helena Laboratories
Chemistry · 15d
Cleared Jul 01, 1981
IL #781, SEMI-AUTOMATED LOADER
K811696 · JQW
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Jul 01, 1981
CHLORIDE/CARBON DIOXIDE RATE REAGENT
K811701 · JFS
Chem-Elec, Inc.
Chemistry · 15d
Cleared Jul 01, 1981
MULTITUBULAR AIR SPLINT KIT
K811704 · IQI
Roger Cestac & Assoc.
Physical Medicine · 15d
Cleared Jul 01, 1981
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
K811708 · BZA
Airlife, Inc.
Anesthesiology · 15d
Cleared Jul 01, 1981
PEDIATRIC OXYGEN MASKS
K811711 · BYG
Airlife, Inc.
Anesthesiology · 14d
Cleared Jun 30, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURES
K810756 · JPK
Scientific Standards, Inc.
Hematology · 102d
Cleared Jun 30, 1981
ALPHA MICRON-40 FILTER
K810761 · CAK
Alpha Therapeutic Corp.
General Hospital · 102d
Cleared Jun 30, 1981
CENTRAL STATION MONITORING SYSTEMS
K811121 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 67d
Cleared Jun 30, 1981
VITA-STAT MODEL 8000-C
K811146 · DSK
Vita-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
VITA-STAT MODEL 9000-A
K811147 · DSK
Vita-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
VITA-STAT MODEL 9000-S
K811148 · DSK
Viat-Stat
Cardiovascular · 64d