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
94441–94464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1997
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE,...
K965083 · ELW
S.S. White Mfg., Ltd.
Dental · 106d
Cleared Apr 04, 1997
SHARPSITE AC
K965233 · EOB
Xomed, Inc.
Ear, Nose, Throat · 94d
Cleared Apr 04, 1997
KODAK EKTASIAN HG FILM (EHG-15)
K970154 · IWZ
Eastman Kodak Company
Radiology · 78d
Cleared Apr 04, 1997
IMEX FUTURALDOP PRO
K970156 · IYO
Imex Medical Systems, Inc.
Radiology · 78d
Cleared Apr 04, 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · ELC
Dentsply Intl.
Dental · 65d
Cleared Apr 04, 1997
PICTURE ARCHIVING & COMMUNICATIONS DEVICE
K970534 · LLZ
Multimedia Solutions
Radiology · 51d
Cleared Apr 04, 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · JAK
GE Medical Systems
Radiology · 45d
Cleared Apr 04, 1997
EASY CAM
K970626 · EIA
I.C.S.
Dental · 44d
Cleared Apr 04, 1997
CLINITEK HCG TEST STRIPS
K971209 · JHI
Bayer Corp.
Chemistry · 2d
Cleared Apr 03, 1997
ATLAS III ACETABULAR CUP
K961388 · MEH
Fournitures Hospitalieres
Orthopedic · 358d
Cleared Apr 03, 1997
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
K962627 · LNI
Siemens Medical Solutions USA, Inc.
Radiology · 272d
Cleared Apr 03, 1997
PERIFIX PEDIATRIC EPIDURAL KIT
K962696 · CAZ
B.Braun Medical, Inc.
Anesthesiology · 266d
Cleared Apr 03, 1997
URODYNAMIC ANALYSIS MODULE
K963330 · FAP
Synectics Medical, Inc.
Gastroenterology & Urology · 223d
Cleared Apr 03, 1997
CTS MIDCAB CORONARY SHUNT
K963503 · DXC
Cardiothoracic Systems, Inc.
Cardiovascular · 212d
Cleared Apr 03, 1997
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
K963616 · IYN
Aloka Co., Ltd.
Radiology · 205d
Cleared Apr 03, 1997
12 URETEROSCOPES/URETERO-RENOSCOPES
K963855 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 190d
Cleared Apr 03, 1997
ULTRATHERM (908)
K964083 · IMJ
Sie-Med, Inc.
Physical Medicine · 174d
Cleared Apr 03, 1997
BIOMET BONE SCREW
K964970 · HWC
Biomet, Inc.
Orthopedic · 112d
Cleared Apr 03, 1997
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · FMT
Hill-Rom, Inc.
General Hospital · 85d
Cleared Apr 03, 1997
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
K970095 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 83d
Cleared Apr 03, 1997
HARMONIES MENSTRUAL TAMPON
K970108 · HEB
Ecoprogress Intl.
Obstetrics & Gynecology · 80d
Cleared Apr 03, 1997
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
K970399 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 59d
Cleared Apr 03, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970462 · KWQ
Acromed Corp.
Orthopedic · 56d
Cleared Apr 03, 1997
COMPASS UNIVERSAL HINGE
K970713 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 35d