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
109681–109704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1994
DIB INFUSOR
K930404 · MEB
Novacon Corp.
General Hospital · 395d
Cleared Feb 25, 1994
KAMPPETER ANOMALOSCOPE
K930575 · HIW
Bova Intl.
Ophthalmic · 386d
Cleared Feb 25, 1994
COAST MEDICAL, INC. RECTAL PROBE
K930930 · FLL
Coast Medical Corp.
General Hospital · 367d
Cleared Feb 25, 1994
CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS
K931748 · LJT
Tri-State Hospital Supply Corp.
General Hospital · 323d
Cleared Feb 25, 1994
NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES
K932634 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 268d
Cleared Feb 25, 1994
HM-880
K932818 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 261d
Cleared Feb 25, 1994
PRIMUS INSULATED FORCEPS
K932832 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 261d
Cleared Feb 25, 1994
PLATO 3000
K933088 · JQW
Rosys, Inc.
Chemistry · 247d
Cleared Feb 25, 1994
COMFORTCARE SYSTEM
K933126 · EYZ
Patsy J. Trisler, J.D.
Gastroenterology & Urology · 242d
Cleared Feb 25, 1994
DETECT (TM) CYTOLOGY BRUSH
K933415 · HHT
Cook Ob/Gyn
Obstetrics & Gynecology · 227d
Cleared Feb 25, 1994
SYRINGE INFUSER
K933506 · FRN
Baxa Corp.
General Hospital · 220d
Cleared Feb 25, 1994
SL SERIES SURGICAL LASER SYSTEMS
K933880 · GEX
Laserscope
General & Plastic Surgery · 199d
Cleared Feb 25, 1994
MEDRAD CT CUSTOM CONVENIENCE KIT
K933908 · DXT
Medrad, Inc.
Cardiovascular · 198d
Cleared Feb 25, 1994
GM CONTINUOUS FLOW BIOPSY PROBE
K933962 · FDC
Gm Engineering, Inc.
Gastroenterology & Urology · 196d
Cleared Feb 25, 1994
HMP POLYSULFONE PORT
K933986 · LJT
Horizon Medical Products, Inc.
General Hospital · 192d
Cleared Feb 25, 1994
HMP TITANIUM PORT
K933990 · LJT
Horizon Medical Products, Inc.
General Hospital · 192d
Cleared Feb 25, 1994
PHX TECHNOLOGIES CORP.,HOOK ELECTRODE, 5MM
K934281 · GEI
Phx Technologies Corp.
General & Plastic Surgery · 178d
Cleared Feb 25, 1994
QMS PHENOBARBITAL
K934388 · LFN
Seradyn, Inc.
Toxicology · 169d
Cleared Feb 25, 1994
HMP DUAL TITANIUM PORT
K934504 · LJT
Horizon Medical Products, Inc.
General Hospital · 163d
Cleared Feb 25, 1994
FASCIA STITCHER
K934527 · GCJ
Laparomed Corp.
General & Plastic Surgery · 158d
Cleared Feb 25, 1994
CONTROL CABLE SYSTEM
K934557 · JDQ
Depuy, Inc.
Orthopedic · 162d
Cleared Feb 25, 1994
HMP TITANIUM LOW PROFILE PORT
K934573 · LJT
Horizon Medical Products, Inc.
General Hospital · 157d
Cleared Feb 25, 1994
ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
K934636 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 25, 1994
HMP DUAL POLYSULFONE PORT
K934640 · LJT
Horizon Medical Products, Inc.
General Hospital · 150d