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
94705–94728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1997
ACUMED SUTURE WASHER
K965028 · HTN
Acu Med, Inc.
Orthopedic · 90d
Cleared Mar 17, 1997
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT...
K965077 · DZE
Implant Innovations, Inc.
Dental · 90d
Cleared Mar 17, 1997
CARDIOBEEPER CB-12L
K965101 · DXH
Meridian Medical Technologies, Inc.
Cardiovascular · 87d
Cleared Mar 17, 1997
DGH MODEL 9000
K965127 · HQC
Dgh Technology, Inc.
Ophthalmic · 84d
Cleared Mar 17, 1997
LIBERTY ANTERIOR SPINAL SYSTEM
K965193 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 83d
Cleared Mar 17, 1997
RADX SYSTEM
K965203 · EHD
Electro Medical Systems, Inc.
Radiology · 81d
Cleared Mar 17, 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · ITX
Hewlett-Packard Co.
Radiology · 73d
Cleared Mar 17, 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · LMD
Autocyt Group, Inc.
Radiology · 69d
Cleared Mar 17, 1997
NEURO-TRAIN II (2)
K970155 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 60d
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