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
107641–107664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1994
INTRASITE
K942748 · NAE
Smith & Nephew United, Inc.
General & Plastic Surgery · 19d
Cleared Jun 28, 1994
BIOJECT JET INJECTION SYSTEM
K920631 · KZE
Bioject, Inc.
General Hospital · 867d
Cleared Jun 28, 1994
ENTEROCLYSIS TUBE
K923002 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 736d
Cleared Jun 28, 1994
DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED
K926332 · IYO
B&K Medical
Radiology · 589d
Cleared Jun 28, 1994
ACUFEX SMOOTH AND THREADED PINS
K931836 · HTY
Acufex Microsurgical, Inc.
Orthopedic · 441d
Cleared Jun 28, 1994
BIO-PREP CEMENT RESTRICTOR
K931847 · LZN
Biomedical Devices, Inc.
Orthopedic · 441d
Cleared Jun 28, 1994
ACUFEX DISPOSABLE MENISCAL CANNULA
K932090 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 424d
Cleared Jun 28, 1994
ACUMED FLEXIBLE CANNULA
K932099 · HRX
Acu Med, Inc.
Orthopedic · 421d
Cleared Jun 28, 1994
OPUS CMV-G
K933389 · LFZ
Pb Diagnostic Systems, Inc.
Microbiology · 351d
Cleared Jun 28, 1994
AVECOR PRE-BYPASS FILTER
K940126 · KRJ
Avecor Cardiovascular, Inc.
Cardiovascular · 169d
Cleared Jun 28, 1994
EYE TRAY
K940239 · LRP
Cush Medical Products
General & Plastic Surgery · 160d
Cleared Jun 28, 1994
RE-SHARPENABLE SAW BLADES
K940501 · GFA
Adven Medical
General & Plastic Surgery · 146d
Cleared Jun 28, 1994
R&D BATTERIES, PART NOS. 5243, 5104, AND 5481
K942033 · BTA
R & D Batteries, Inc.
General & Plastic Surgery · 61d
Cleared Jun 27, 1994
HEMOSPAL KIT B22 / MULTIFLOW 60 KIT
K924437 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 664d
Cleared Jun 27, 1994
HELLER TRANSILLUMINATING STYLETTE
K925061 · KNT
Device Resources
Gastroenterology & Urology · 629d
Cleared Jun 27, 1994
THE BTE VECTOR
K925225 · KQX
Baltimore Therapeutic Equipment Co.
Neurology · 619d
Cleared Jun 27, 1994
ELECTROSURGICAL ELECTRODE
K925478 · HGI
Megadyne Medical Products, Inc.
Obstetrics & Gynecology · 606d
Cleared Jun 27, 1994
VENUS DIAGNOSTIC ULTRASOUND SYSTEM
K933202 · IYN
GE Medical Systems
Radiology · 361d
Cleared Jun 27, 1994
COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
K933768 · HET
Mahe-Medizintechnik
Obstetrics & Gynecology · 333d
Cleared Jun 27, 1994
SATURN LIGHT
K935102 · FTA
Burton Medical Products Corp.
General & Plastic Surgery · 248d
Cleared Jun 27, 1994
VOLUME NECK COIL FOR THE GYREX V-DIX
K935224 · LNH
Elscint, Inc.
Radiology · 238d
Cleared Jun 27, 1994
HM-CRYO
K940140 · GEH
Hill-Med, Inc.
General & Plastic Surgery · 167d
Cleared Jun 27, 1994
PACSPRO II
K941086 · LMD
Advanced Video Products, Inc.
Radiology · 111d
Cleared Jun 27, 1994
MEDICAL IMAGING WORKSTATION II (MIW II)
K941203 · LMD
Cemco, Inc.
Radiology · 105d