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
109033–109056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1994
ASSESS(TM) HIGH ABNORMAL CONTROL
K931118 · GJS
Instrumentation Laboratory CO
Hematology · 391d
Cleared Mar 30, 1994
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT
K931922 · JSM
Viratest Intl., Inc.
Microbiology · 348d
Cleared Mar 30, 1994
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K931966 · IKT
Dantec Medical, Inc.
Neurology · 343d
Cleared Mar 30, 1994
VENTANA NEGATIVE CONTROL REAGENT
K931979 · DEM
Ventana Medical Systems, Inc.
Immunology · 342d
Cleared Mar 30, 1994
MARTIN COLD LIGHT FOUNTAIN
K932060 · GCJ
Medline
General & Plastic Surgery · 335d
Cleared Mar 30, 1994
KAPTON PEEL POUCH
K933228 · KJA
American Fluoroseal Corp.
Pathology · 271d
Cleared Mar 30, 1994
MERITS WHEELCHAIR
K933662 · ITI
Merits Health Products., Inc.
Physical Medicine · 246d
Cleared Mar 30, 1994
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS...
K934539 · GKL
Intl. Remote Imaging Systems
Microbiology · 194d
Cleared Mar 30, 1994
CATHEJELL S STERILE LUBRICATING JELLY
K935548 · FHX
Pharmazeutische Fabrik Montavit GmbH
Gastroenterology & Urology · 133d
Cleared Mar 30, 1994
CUSTOM ENT PACKS
K935621 · LRP
Associated Medical
General & Plastic Surgery · 128d
Cleared Mar 30, 1994
VERSION 3 OPERATING SYSTEM SOFTWARE
K935670 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 124d
Cleared Mar 30, 1994
2D, 3D TOF MR ANGIOGRAPHY
K935671 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 124d
Cleared Mar 30, 1994
LABOR AND DELIVERY TRAY
K936120 · MLS
Cush Medical Products
Obstetrics & Gynecology · 97d
Cleared Mar 30, 1994
ENLINE ENDOSCOPIC SURGICAL INSTRUMENTS
K940155 · GCJ
Surgigus Instruments, Inc.
General & Plastic Surgery · 86d
Cleared Mar 30, 1994
ENVOY GUIDING CATHETER
K940187 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 76d
Cleared Mar 30, 1994
DISSECTOR
K940199 · GCJ
Automated Medical Products Corp.
General & Plastic Surgery · 76d
Cleared Mar 30, 1994
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 76d
Cleared Mar 30, 1994
PETROLATUM DRESSING
K940693 · FRO
Medtrax Industries, Inc.
General & Plastic Surgery · 42d
Cleared Mar 30, 1994
XEROFORM PETROLATUM DRESSING
K940694 · FRO
Medtrax Industries, Inc.
General & Plastic Surgery · 42d
Cleared Mar 30, 1994
ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE
K940909 · GEI
Debusk Technology Corp.
General & Plastic Surgery · 35d
Cleared Mar 30, 1994
RAREX GREEN FAST
K941023 · EAM
Mci Optonix, Inc.
Radiology · 27d
Cleared Mar 29, 1994
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · HRX
Smith & Nephew, Inc.
Orthopedic · 685d
Cleared Mar 29, 1994
CIDEX PLUS 28 DAY SOLUTION
K923744 · LRJ
Johnson & Johnson Medical, Inc.
General Hospital · 609d
Cleared Mar 29, 1994
CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE
K924334 · MED
Johnson & Johnson Medical, Inc.
General Hospital · 579d