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
76033–76056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106 · DTR
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared Apr 10, 2002
UD-1000 ULTRASONIC A/B SCANNER
K020151 · IYO
Tomey Corp. USA
Radiology · 84d
Cleared Apr 10, 2002
SURGASSIST SYSTEM
K020343 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 68d
Cleared Apr 10, 2002
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS...
K020363 · LYY
Great Glove Sdn Bhd
General Hospital · 65d
Cleared Apr 10, 2002
BIOCELLECT -PERIO
K020396 · LYC
Imtec Corp.
Dental · 63d
Cleared Apr 10, 2002
SIMPLICITY EASY SOFT INFUSION SET
K020912 · FPA
Sterling Medivations, Inc.
General Hospital · 21d
Cleared Apr 10, 2002
SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS...
K020990 · FPA
Sterling Medivations, Inc.
General Hospital · 14d
Cleared Apr 09, 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · DTB
Biotronik, Inc.
Cardiovascular · 434d
Cleared Apr 09, 2002
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
K012325 · KFM
Cardiovention, Inc.
Cardiovascular · 260d
Cleared Apr 09, 2002
URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC...
K012758 · FGB
Circon Video
Gastroenterology & Urology · 235d
Cleared Apr 09, 2002
FRIALOC DENTAL IMPLANT SYSTEM
K013067 · DZE
Friadent GmbH
Dental · 209d
Cleared Apr 09, 2002
ASTRONOMER PLUS SYSTEM
K013349 · DQK
Ep Technologies, Inc.
Cardiovascular · 182d
Cleared Apr 09, 2002
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
K014025 · DQA
Hommed, LLC
Anesthesiology · 124d
Cleared Apr 09, 2002
ATHOS LASER
K020072 · GEX
Quantel Medical
General & Plastic Surgery · 90d
Cleared Apr 09, 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · LPL
Ciba Vision Corporation
Ophthalmic · 83d
Cleared Apr 09, 2002
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
K020376 · EMA
Advanced Healthcare , Ltd.
Dental · 64d
Cleared Apr 09, 2002
STRATASIS SLING KIT
K020654 · PAG
Cook Biotech, Inc.
Gastroenterology & Urology · 40d
Cleared Apr 09, 2002
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K020832 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Apr 09, 2002
MODEL GT010706 ELECTRONIC THERMOMETER
K021052 · FLL
Global Treasure Industries , Ltd.
General Hospital · 8d
Cleared Apr 08, 2002
MONITORING SYSTEM,MODEL ARGUS PB-1000
K012226 · MHX
Schiller AG
Cardiovascular · 266d
Cleared Apr 08, 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330,...
K012417 · JOW
Hygia Health Services, Inc.
Cardiovascular · 252d
Cleared Apr 08, 2002
AL-2000 COMBINED BIOMETER AND PACHYMETER
K012803 · IYO
Tomey Corp.
Radiology · 230d
Cleared Apr 08, 2002
BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
K013672 · JEY
Azary Technologies, LLC
Dental · 153d
Cleared Apr 08, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000
K013848 · IYN
U-Systems, Inc.
Radiology · 139d