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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130561–130584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1989
SUPER DUO
K892802 · JWZ
Mercia Diagnostics , Ltd.
Microbiology · 57d
Cleared Jun 13, 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · JSO
Remel Co.
Microbiology · 53d
Cleared Jun 13, 1989
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K893439 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 13, 1989
IRISTAIN FORMULA 2, PARTS 1 AND 2
K893530 · JTS
Intl. Remote Imaging Systems
Pathology · 36d
Cleared Jun 13, 1989
INSTANT EOSIN-AQUEOUS
K893663 · HYB
Shandon, Inc.
Pathology · 29d
Cleared Jun 12, 1989
RESUBMITTAL OF MI 1000C MICROIMAGER
K881979 · JOP
Ausonics Pty , Ltd.
Cardiovascular · 396d
Cleared Jun 12, 1989
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · LCJ
Mentor Corp.
General & Plastic Surgery · 244d
Cleared Jun 12, 1989
ADVENT VENTILATOR
K884793 · CBK
Ohmeda Medical
Anesthesiology · 208d
Cleared Jun 12, 1989
MODEL 1010, CY-MET
K884910 · BZK
Cybermedic, Inc.
Anesthesiology · 199d
Cleared Jun 12, 1989
CM 7000MR
K890010 · CAP
Trudell Medical
Anesthesiology · 160d
Cleared Jun 12, 1989
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
K890072 · KNY
Medireach, Inc.
Gastroenterology & Urology · 154d
Cleared Jun 12, 1989
PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350)
K890198 · DXN
Paramed Technology, Inc.
Cardiovascular · 145d
Cleared Jun 12, 1989
DENTAL X-RAY BITE BLOCK
K890355 · EGZ
Bite-A-Block
Dental · 139d
Cleared Jun 12, 1989
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
K890637 · HEM
Elscint, Inc.
Obstetrics & Gynecology · 124d
Cleared Jun 12, 1989
ROTATING HEMOSTATIC VALVE
K890800 · LIT
Datascope Corp.
Cardiovascular · 116d
Cleared Jun 12, 1989
CAV 3.0C SOFTWARE PROGRAM
K890932 · BZK
Siemens Life Support Systems
Anesthesiology · 108d
Cleared Jun 12, 1989
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
K891408 · JDX
Depuy, Inc.
Orthopedic · 90d
Cleared Jun 12, 1989
MODEL 116 FETAL MONITOR
K891595 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 84d
Cleared Jun 12, 1989
MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.
K891611 · LJT
Medtronic Versaflex, Inc.
General Hospital · 84d
Cleared Jun 12, 1989
DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.
K891612 · EFD
Implant Innovations International, Inc.
Dental · 84d
Cleared Jun 12, 1989
NEOCHROME(R) III GLUCOSE
K892002 · CGA
American Monitor Corp.
Chemistry · 76d
Cleared Jun 12, 1989
FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED
K892207 · DRF
Ep Technologies, Inc.
Cardiovascular · 70d
Cleared Jun 12, 1989
DENTAL PLASTIC BITE FORK
K892373 · EJP
Texapol Corp.
Dental · 67d
Cleared Jun 12, 1989
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · BTR
The Kendal Co.
Anesthesiology · 63d