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
94201–94224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1997
IL0292 DP ECHOPORT
K970555 · EWO
Smith
Ear, Nose, Throat · 32d
Cleared Mar 14, 1997
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
K950017 · KNT
Ross Products
Gastroenterology & Urology · 801d
Cleared Mar 14, 1997
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
K964117 · LJT
Kawasumi Laboratories Co., Ltd.
General Hospital · 150d
Cleared Mar 14, 1997
TOPAZ 30 SURGICAL LASER SYSTEM
K965015 · GEX
Esc Medical Systems, Inc.
General & Plastic Surgery · 88d
Cleared Mar 14, 1997
REGIONAL ANESTHESIA TRAYS
K965017 · CAZ
Smiths Industries Medical Systems, Inc.
Anesthesiology · 88d
Cleared Mar 14, 1997
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
K965020 · CAH
Porous Media Corp.
General Hospital · 88d
Cleared Mar 14, 1997
ISOLA TWISTER CONNECTOR
K965046 · MNH
Acromed Corp.
Orthopedic · 86d
Cleared Mar 14, 1997
OOLI-U(TONGUE SCRAPER)
K970042 · LCN
Telefax Intl.
Dental · 67d
Cleared Mar 14, 1997
ULTRACAL XS
K970114 · EJK
Ultradent Products, Inc.
Dental · 60d
Cleared Mar 14, 1997
MOBILE OPERATING TABLE 1132.01
K970807 · GDC
Stierlen-Maquet AG
General & Plastic Surgery · 9d
Cleared Mar 14, 1997
BLUE CHIP GERMICIDAL CLEANER & DEODORANT
K970825 · LRJ
S.C. Johnson Professional
General Hospital · 8d
Cleared Mar 13, 1997
MEDVISION PERSONAL MONITOR
K961343 · GCJ
Medvision, Inc.
General & Plastic Surgery · 339d
Cleared Mar 13, 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · HSB
Encore Orthopedics, Inc.
Orthopedic · 338d
Cleared Mar 13, 1997
MANAN D BAG
K961986 · EXF
Manan Medical Products, Inc.
Gastroenterology & Urology · 296d
Cleared Mar 13, 1997
SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR...
K962109 · GEX
Classy Lady by Mehl of Puerto Rico, Inc.
General & Plastic Surgery · 286d
Cleared Mar 13, 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
K962723 · LBR
Trace America, Inc.
Chemistry · 241d
Cleared Mar 13, 1997
NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM
K962791 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 239d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · DSH
Del Mar Avionics
Cardiovascular · 211d
Cleared Mar 13, 1997
SYSMEX SE/RAM-1
K964375 · GKL
Sysmex Corp.
Hematology · 132d
Cleared Mar 13, 1997
IMPLEX REPLACEMENT ACETABULAR CUP INSERT
K964882 · LPH
Implex Corp.
Orthopedic · 98d
Cleared Mar 13, 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · KWP
Depuy, Inc.
Orthopedic · 80d
Cleared Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · LPH
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
HOWMEDICA MAINSTAY ANCHOR
K965175 · JDR
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
BIORIGID NAIL TIBIA
K970013 · HTY
Aap GmbH and Co. Betriebs KG
Orthopedic · 70d