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
85009–85032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 02, 1999
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
K991866 · CIG
A.P. Total Care, Inc.
Chemistry · 62d
Cleared Aug 02, 1999
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
K991867 · CEO
A.P. Total Care, Inc.
Chemistry · 62d
Cleared Aug 02, 1999
MEDTRONIC AVE BRIDGE STENT
K992318 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 02, 1999
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438 · LTZ
Indus Medicare , Ltd.
Obstetrics & Gynecology · 11d
Cleared Jul 30, 1999
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
K982859 · HRY
Plus Orthopedics
Orthopedic · 351d
Cleared Jul 30, 1999
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB,...
K983802 · MJN
Lucas Medical, Inc.
Cardiovascular · 275d
Cleared Jul 30, 1999
AGC V2 REVISION KNEE SYSTEM
K984054 · JWH
Biomet, Inc.
Orthopedic · 259d
Cleared Jul 30, 1999
AVE GL-1 GUIDING CATHETER
K984482 · DQY
Arterial Vascular Engineering...
Cardiovascular · 226d
Cleared Jul 30, 1999
HT, MODEL HT PB
K990142 · DTB
Sulzer Oscor, Inc.
Cardiovascular · 192d