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
93937–93960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 02, 1997
SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE
K952912 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 646d
Cleared Apr 02, 1997
STERITEC DRY HEAT INDICATOR LABEL
K953122 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 637d
Cleared Apr 02, 1997
MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR
K954120 · CCK
Magnetic Resonance Equipment Corp.
Anesthesiology · 579d
Cleared Apr 02, 1997
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · HSD
Biomet, Inc.
Orthopedic · 365d
Cleared Apr 02, 1997
IMMULITE RUBELLA IGG
K963613 · LFX
Diagnostic Products Corp.
Microbiology · 204d
Cleared Apr 02, 1997
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
K963631 · OLZ
Omega Results
Neurology · 203d
Cleared Apr 02, 1997
MICS DEVICE SYSTEM
K963716 · DXC
Percutaneous Technologies, Inc.
Cardiovascular · 198d
Cleared Apr 02, 1997
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
K964038 · KLE
Heraeus Kulzer, Inc.
Dental · 180d
Cleared Apr 02, 1997
PRIMARY IV SET
K964435 · FMG
Icu Medical, Inc.
General Hospital · 148d