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
75505–75528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 30d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS...
K020824 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Apr 12, 2002
EFILM WORKSTATION WITH MODULES
K020995 · LLZ
Efilm Medical, Inc.
Radiology · 15d
Cleared Apr 12, 2002
ABP-2000 G-3
K021029 · DXN
Biotrac, Inc.
Cardiovascular · 14d
Cleared Apr 11, 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 601d
Cleared Apr 11, 2002
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L
K011068 · KTL
Rhigene, Inc.
Immunology · 367d
Cleared Apr 11, 2002
ZOLL PAD WITH CPR AID
K011541 · MKJ
Zoll Medical Corp
Cardiovascular · 328d
Cleared Apr 11, 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
K012956 · JOW
Hygia Health Services, Inc.
Cardiovascular · 219d
Cleared Apr 11, 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 202d
Cleared Apr 11, 2002
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
K020099 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Apr 11, 2002
INTRAORAL CAMERA ME-15
K020206 · EIA
Dent Corp. Research & Development
Dental · 79d
Cleared Apr 11, 2002
AVON PATELLAR COMPONENT
K020841 · KRR
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 11, 2002
MODIFICATION TO FOX PTA CATHETER
K020854 · LIT
Jomed AG
Cardiovascular · 27d
Cleared Apr 10, 2002
IMMEDIATE STABILIZING DEVICE (ISD)
K011524 · DZE
"O" Co., Inc.
Dental · 328d
Cleared Apr 10, 2002
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
K020089 · NIE
The Kendall Company
Gastroenterology & Urology · 90d
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