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
109321–109344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 1994
MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA
K933295 · LNH
Medic, Inc.
Radiology · 253d
Cleared Mar 17, 1994
MODEL #310GE1500 WRIST COIL
K933296 · LNH
Medic, Inc.
Radiology · 253d
Cleared Mar 17, 1994
100 SERIES ENDOSCOPIC GRASPING FORCEPS
K933698 · HET
Cook Urological, Inc.
Obstetrics & Gynecology · 231d
Cleared Mar 17, 1994
APEX MEDICAL AIR PUMPS
K933965 · FNM
Apex Medical, Inc.
General Hospital · 213d
Cleared Mar 17, 1994
VISION (MANUAL WHEELCHAIR)
K934234 · IOR
Fortress Lite-Style Wheelchairs, Inc.
Physical Medicine · 210d
Cleared Mar 17, 1994
LEGEND (MANUAL WHEELCHAIR)
K934236 · IOR
Fortress Lite-Style Wheelchairs, Inc.
Physical Medicine · 210d
Cleared Mar 17, 1994
HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS
K934451 · HET
Cook Urological, Inc.
Obstetrics & Gynecology · 185d
Cleared Mar 17, 1994
VERIFUSE AMBULATORY PUMP
K934551 · MEA
Block Medical, Inc.
General Hospital · 176d
Cleared Mar 17, 1994
WIDEX R.C. 2 (REMOTE CONTROL)
K935424 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 127d
Cleared Mar 17, 1994
INSUFFLATION TUBING STERILE AND NON-STERILE
K935639 · HIF
Charles Polo & Co., Inc.
Obstetrics & Gynecology · 114d
Cleared Mar 17, 1994
STERILE VIDEO CAMERA COVER AND DRAPE
K936086 · KXK
Micromedical Devices, Inc.
Radiology · 86d
Cleared Mar 17, 1994
AUROLITE 2A
K940485 · EJT
Argen Precious Metals, Inc.
Dental · 43d
Cleared Mar 17, 1994
AURIUM 239
K940579 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Mar 17, 1994
AUROLITE 6
K940580 · EJT
Argen Precious Metals, Inc.
Dental · 37d
Cleared Mar 17, 1994
AUROLITE 9
K940610 · EJT
Argen Precious Metals, Inc.
Dental · 31d
Cleared Mar 16, 1994
VITAL-COMBO(R)
K922315 · LDD
Physio-Control Corp.
Cardiovascular · 667d
Cleared Mar 16, 1994
BEBIG PLAQUES RUM101-RUM114
K931393 · KXK
Bebig, Inc.
Radiology · 362d
Cleared Mar 16, 1994
RADSTAT
K932564 · LLZ
Dimensional Medicine, Inc.
Radiology · 293d
Cleared Mar 16, 1994
E-FAX REMOTE MONITOR
K932863 · DXH
Coherent Systems, Inc.
Cardiovascular · 278d
Cleared Mar 16, 1994
ARM RADIATION BEAM SCANNER
K933558 · IYE
Advanced Radiation Measurements, Inc.
Radiology · 238d
Cleared Mar 16, 1994
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
K933595 · GFA
Omega Surgical Instruments, Inc.
General & Plastic Surgery · 233d
Cleared Mar 16, 1994
OPTIK LAPAROSCOPE
K933776 · GCJ
Optik
General & Plastic Surgery · 225d
Cleared Mar 16, 1994
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX
K934483 · ESE
Mountain Precision Mfg. Ltd. Co.
Ear, Nose, Throat · 183d
Cleared Mar 16, 1994
STERILE DESIGN
K934688 · LRO
Sterile Design, Inc.
General & Plastic Surgery · 167d