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
71233–71256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2003
RAPIDO CUT-AWAY GUIDING CATHETER
K031505 · DQY
Guidant Corporation
Cardiovascular · 42d
Cleared Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
K031644 · JJY
Bayer Healthcare, LLC
Chemistry · 29d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Jun 25, 2003
LIPOPROTEIN CALIBRATOR
K031682 · JIX
Bayer Healthcare, LLC
Chemistry · 26d
Cleared Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
K031756 · CGN
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · MHX
Datex-Ohmeda
Cardiovascular · 15d
Cleared Jun 24, 2003
ASYRA
K023355 · GZO
Galloway Technologies, LLC
Neurology · 260d
Cleared Jun 24, 2003
UF BRACHYTHERAPY STAND
K023430 · IYO
University of Florida
Radiology · 256d
Cleared Jun 24, 2003
BD VIPER INSTRUMENT
K023955 · JQW
Becton, Dickinson & CO
Microbiology · 209d
Cleared Jun 24, 2003
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM...
K024270 · CAH
Intersurgical, Inc.
General Hospital · 183d
Cleared Jun 24, 2003
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
K030578 · NAY
Computer Motion, Inc.
General & Plastic Surgery · 120d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 24, 2003
ECLIPSE
K030981 · LNH
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Jun 24, 2003
MODIFICATION TO TRANSPORT INCUBATOR 185
K031096 · FPL
International Biomedics, Inc.
General Hospital · 78d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · JDW
Sintea Biotech, Inc.
Orthopedic · 74d
Cleared Jun 24, 2003
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · FMI
Becton, Dickinson & CO
General Hospital · 69d
Cleared Jun 24, 2003
SYNVITRO HYADASE
K031228 · MQL
Medicult A/S
Obstetrics & Gynecology · 67d
Cleared Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K031393 · NIG
Bayer Healthcare, LLC
Immunology · 53d
Cleared Jun 24, 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460 · BZD
Respironics, Inc.
Anesthesiology · 47d
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · LPH
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · KWP
U&I Corp., America
Orthopedic · 34d
Cleared Jun 24, 2003
SPECTRAPULSE
K031680 · GEX
Primary Technology, LLC
General & Plastic Surgery · 25d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · KTT
Synthes (Usa)
Orthopedic · 21d
Cleared Jun 24, 2003
ENDO GATOR SYSTEM
K031773 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 15d