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
101689–101712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1995
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS
K944947 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 294d
Cleared Jul 28, 1995
NIPLETTE
K952035 · HGY
Avent America, Inc.
Obstetrics & Gynecology · 88d
Cleared Jul 28, 1995
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K952344 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 28, 1995
SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE
K952518 · FMI
Medi-Dose, Inc.
General Hospital · 102d
Cleared Jul 28, 1995
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS...
K952638 · LYK
Baxter Edwards
Cardiovascular · 49d
Cleared Jul 28, 1995
HEARING AID
K952658 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 46d
Cleared Jul 28, 1995
ESSENTIAL SHAVER SYSTEM
K953096 · EQJ
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 25d
Cleared Jul 28, 1995
CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
K953314 · MOV
Conceptus, Inc.
Obstetrics & Gynecology · 16d
Cleared Jul 27, 1995
MULTIPACE
K934785 · LDF
Electro-Catheter Corp.
Cardiovascular · 660d
Cleared Jul 27, 1995
ECHO-SCAN
K941322 · IYO
Tomographic Tech
Radiology · 496d
Cleared Jul 27, 1995
DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
K951447 · DWZ
Portlyn Corp.
Cardiovascular · 120d
Cleared Jul 27, 1995
MESH TITANIUM IMPLANT SYSTEM
K951687 · JEY
Medicon EG
Dental · 113d
Cleared Jul 27, 1995
TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM
K951689 · JEY
Medicon EG
Dental · 113d
Cleared Jul 27, 1995
COLD LIGHT SOURCE LOS XL-A 100
K952028 · GCT
Laser Optik Systeme GmbH & Co. KG
Gastroenterology & Urology · 87d
Cleared Jul 27, 1995
SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER
K952074 · FPA
Baxter Healthcare Corp
General Hospital · 86d
Cleared Jul 27, 1995
PROCLEAR DAILY WEAR CONTACT LENS
K952152 · LPL
Biocompatibles , Ltd.
Ophthalmic · 80d
Cleared Jul 27, 1995
REMATITAN TITANIUM
K952866 · EJH
Dentauraum, Inc.
Dental · 35d
Cleared Jul 27, 1995
REMANIUM:GM 700, GM 380, GM 800, GFH
K952867 · EJH
Dentauraum, Inc.
Dental · 35d
Cleared Jul 27, 1995
REMANIUM: CS & G-SOFT
K952870 · EJH
Dentauraum, Inc.
Dental · 35d
Cleared Jul 27, 1995
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · KRA
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Jul 26, 1995
BIO-COR COLLAGEN CORNEAL SHIELD
K944872 · MOE
Bausch & Lomb Healthcare and Optics...
Ophthalmic · 296d
Cleared Jul 26, 1995
DURAPHAT
K945794 · LBH
Inpharma
Dental · 243d
Cleared Jul 26, 1995
DOPPLEX SURGICAL PROBES
K946300 · ITX
Hne Healthcare, Inc.
Radiology · 210d
Cleared Jul 26, 1995
CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE
K950597 · FPA
Distronic Sterile Products, Inc.
General Hospital · 167d