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
115705–115728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1992
BIOSELF 2000 FERTILITY INDICATOR
K904211 · LHD
Bioself, Inc.
Obstetrics & Gynecology · 763d
Cleared Oct 14, 1992
LITTLE PRISM
K913659 · KPR
Octostop, Inc.
Radiology · 434d
Cleared Oct 14, 1992
GENTLE SLOPE
K913711 · KPR
Octostop, Inc.
Radiology · 434d
Cleared Oct 14, 1992
OX-600
K920196 · KPX
Stardard X-Ray Sales Co.
Radiology · 273d
Cleared Oct 14, 1992
CONTOURING DEVICE
K920506 · KPQ
X-Icon Medical Systems
Radiology · 252d
Cleared Oct 14, 1992
KING OF HEARTS EXPRESS (E.X.) MONITOR
K920984 · DXH
Instromedix, Inc.
Cardiovascular · 226d
Cleared Oct 14, 1992
DATASCOPE PASSPORT MONITOR WITH CO2
K921526 · CCK
Datascope Corp.
Anesthesiology · 197d
Cleared Oct 14, 1992
C-TRAK BIOPSY SYSTEM
K922117 · IZD
Care Wise Medical Products Corp.
Radiology · 162d
Cleared Oct 14, 1992
RAPID NFT, MODIFICATION
K922768 · JSW
Biomerieux Vitek, Inc.
Microbiology · 128d
Cleared Oct 14, 1992
KODAK AMERLEX MAB FT3 ASSAY
K922771 · CDP
Eastman Kodak Company
Chemistry · 127d
Cleared Oct 14, 1992
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · CDX
Heraeus Kulzer, Inc.
Chemistry · 118d
Cleared Oct 14, 1992
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048 · CGA
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Oct 14, 1992
COULTER MULTI-Q-PREP
K923530 · GKH
Coulter Electronics, Inc.
Hematology · 90d
Cleared Oct 14, 1992
SIENET CAMERA SERVER
K923582 · LMD
Siemens Gammasonics, Inc.
Radiology · 86d
Cleared Oct 14, 1992
REDI-CHECK PHOTMETER Q.A.
K923598 · JFS
Awareness Technology, Inc.
Chemistry · 86d
Cleared Oct 14, 1992
TWO PART INORGANIC PHOSPHORUS TEST
K924470 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Oct 13, 1992
INTERPORE IMZ CYLINDER IMPLANT SYSTEM
K913228 · DZE
Interpore Intl.
Dental · 449d
Cleared Oct 13, 1992
QUICK SEEDER
K913293 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 447d
Cleared Oct 13, 1992
SAFEDWEL(R) CENTRAL VENOUS CATHETER
K914528 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 370d
Cleared Oct 13, 1992
INTELECT 600MP
K920260 · GZJ
Chattanooga Group, Inc.
Neurology · 266d
Cleared Oct 13, 1992
SUBCUTANEOUS INFUSION SET
K920537 · FPA
Marquette Medical, Inc.
General Hospital · 251d
Cleared Oct 13, 1992
RASCAL II
K920622 · CCK
Ohmeda Medical
Anesthesiology · 245d
Cleared Oct 13, 1992
DRIGEL DEFIBRILLATOR/SYNCHRONIZED COARDIOVERSION
K921207 · DRX
Physiometrix, Inc.
Cardiovascular · 215d
Cleared Oct 13, 1992
JET VENTILATOR/JETTING DEVICE
K921926 · BTL
Anesthesia Assoc., Inc.
Anesthesiology · 172d