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
85513–85536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747 · LYR
Quidel Corp.
Microbiology · 75d
Cleared Aug 04, 1999
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K991903 · GWE
Excel Tech. , Ltd.
Neurology · 61d
Cleared Aug 04, 1999
INTRASTENT
K991929 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 04, 1999
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW...
K992275 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 04, 1999
VINYL POWDERED EXAM GLOVE / CAT.# 15-020
K992289 · LYZ
Vitalcare Group, Inc.
General Hospital · 28d
Cleared Aug 03, 1999
INTER-OP METASUL ACETABULAR SYSTEM
K974728 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 593d
Cleared Aug 03, 1999
RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED...
K990619 · BTR
Rusch Intl.
Anesthesiology · 159d
Cleared Aug 03, 1999
CARESIDE AMMONIA
K991371 · JID
Careside, Inc.
Chemistry · 105d
Cleared Aug 03, 1999
SOLUSTAPLE
K991566 · JDR
New Deal, S.A.
Orthopedic · 90d
Cleared Aug 03, 1999
HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
K991569 · CAW
02 Marketing Group, Inc.
Anesthesiology · 90d
Cleared Aug 03, 1999
EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
K991642 · GWN
Bertec Corp.
Neurology · 82d
Cleared Aug 03, 1999
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K991652 · LNH
Siemens Corp.
Radiology · 82d
Cleared Aug 03, 1999
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
K992126 · GCX
Circon Corp.
General Hospital · 41d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
K992387 · DPW
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
K992388 · DPW
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared Aug 02, 1999
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
K990854 · FGE
Innerdyne, Inc.
Gastroenterology & Urology · 140d
Cleared Aug 02, 1999
DUET II GLUCOSE CONTROL MONITORING SYSTEM
K990942 · CGA
Lxn Corp.
Chemistry · 133d
Cleared Aug 02, 1999
N LATEX STFR REAGENT
K991157 · DDG
Dade Behring, Inc.
Immunology · 117d
Cleared Aug 02, 1999
TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND...
K991565 · KPS
Smv America
Radiology · 89d
Cleared Aug 02, 1999
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED...
K991629 · LLZ
Ge Medical Systems, Inc.
Radiology · 83d
Cleared Aug 02, 1999
QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
K991724 · MOS
Medical Advances, Inc.
Radiology · 74d
Cleared Aug 02, 1999
OPART, MODEL MRT-600
K991740 · MOS
Toshiba America Mri, Inc.
Radiology · 73d
Cleared Aug 02, 1999
SYNERGY SHOULDER COIL
K991765 · MOS
Philips Medical Systems North...
Radiology · 70d
Cleared Aug 02, 1999
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
K991805 · IYN
Acuson Corp.
Radiology · 68d