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
84913–84936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1999
SOUND VASER SYSTEM
K991791 · LFL
Sound Surgical Technologies, LLC
General & Plastic Surgery · 79d
Cleared Aug 12, 1999
CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
K991792 · GEH
Influence, Inc.
General & Plastic Surgery · 78d
Cleared Aug 12, 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT...
K991820 · LYR
Zeus Scientific, Inc.
Microbiology · 77d
Cleared Aug 12, 1999
ULTIMAX HAIG II NAIL SYSTEM
K991889 · LXT
Encore Orthopedics, Inc.
Orthopedic · 70d
Cleared Aug 12, 1999
RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
K991895 · HHK
Ri Mos. S.R.L.
Obstetrics & Gynecology · 70d
Cleared Aug 12, 1999
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
K991920 · KMF
Dermaphylyx, Inc.
General & Plastic Surgery · 66d
Cleared Aug 12, 1999
CTD MARK I TRACTION DEVICE
K991931 · ITH
Therasys, Inc.
Physical Medicine · 65d
Cleared Aug 12, 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
K991949 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 64d
Cleared Aug 12, 1999
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
K991950 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 64d
Cleared Aug 12, 1999
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K992029 · LBR
Elan Diagnostics
Chemistry · 57d
Cleared Aug 12, 1999
MANUAL WHEELCHAIR
K992035 · IOR
Major Mobility Products, Inc.
Physical Medicine · 57d
Cleared Aug 12, 1999
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · INI
Invacare Corp.
Physical Medicine · 55d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109 · LPH
Encore Orthopedics, Inc.
Orthopedic · 51d
Cleared Aug 12, 1999
KINEMATIC II ROTATING HINGE KNEE
K992346 · LGE
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Aug 12, 1999
SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
K992363 · FRO
Euromed, Inc.
General & Plastic Surgery · 28d
Cleared Aug 12, 1999
EXPRESSEYE
K992473 · GWN
Optomotor Laboratories
Neurology · 17d
Cleared Aug 12, 1999
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
K992499 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 17d
Cleared Aug 12, 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · FYA
Allegiance Healthcare Corp.
General Hospital · 15d
Cleared Aug 11, 1999
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
K983333 · FYD
Buffalo Filter Co., Inc.
General Hospital · 322d
Cleared Aug 11, 1999
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
K983364 · FYD
Buffalo Filter Co., Inc.
General Hospital · 321d
Cleared Aug 11, 1999
JETSONIC 2000
K990545 · KOJ
Sds Dental, Inc.
Dental · 170d
Cleared Aug 11, 1999
GONOSTAT GONOCOCCAL DETECTION KIT
K991268 · LSL
Sierra Diagnostics
Microbiology · 120d
Cleared Aug 11, 1999
PARAGON
K991481 · EJJ
Lancer Orthodontics, Inc.
Dental · 105d
Cleared Aug 11, 1999
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
K991776 · LZA
Seltom Pacific Sdn. Bhd.
General Hospital · 78d