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
119713–119736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1991
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
K905709 · LCP
Beckman Instruments, Inc.
Hematology · 276d
Cleared Sep 23, 1991
CARDIOSWISS CM-8
K910109 · DSI
Care Systems, Inc.
Cardiovascular · 256d
Cleared Sep 23, 1991
VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS
K910111 · IZH
Instrumentarium Imaging, Inc.
Radiology · 256d
Cleared Sep 23, 1991
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594 · DXT
Dow Corning Wright
Cardiovascular · 223d
Cleared Sep 23, 1991
RIGHT ATRIAL CATHETERS
K911333 · DQY
Akcess Medical Products, Inc.
Cardiovascular · 181d
Cleared Sep 23, 1991
G-PIN
K911375 · HTY
Dr.M.A.Galluzzo
Orthopedic · 179d
Cleared Sep 23, 1991
MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM)
K911604 · LDD
Medphone Corp.
Cardiovascular · 166d
Cleared Sep 23, 1991
ANTI-JO-1 MICROASSAY
K911679 · LLL
Diamedix Corp.
Immunology · 161d
Cleared Sep 23, 1991
IMAC2000
K911764 · JAK
Medical Imaging Technologies, Inc.
Radiology · 157d
Cleared Sep 23, 1991
NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
K911784 · BTQ
North American Sterilization &...
Anesthesiology · 154d
Cleared Sep 23, 1991
ANTI-DNA MICROASSAY
K912020 · LRM
Diamedix Corp.
Immunology · 139d
Cleared Sep 23, 1991
CHOLANGIOGRAPHY CATHETER
K912122 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 132d
Cleared Sep 23, 1991
LIFECARE CPAP-100
K912224 · BZD
Lifecare Services, Inc.
Anesthesiology · 126d
Cleared Sep 23, 1991
WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
K912288 · FGE
Wiltek Medical, Inc.
Gastroenterology & Urology · 123d
Cleared Sep 23, 1991
BIPURE 1000
K912347 · FYD
Laser Engineering, Inc.
General Hospital · 118d
Cleared Sep 23, 1991
BIOMERIEUX RSV DIRECT IF KIT
K912371 · LKT
Vitek Systems, Inc.
Microbiology · 117d
Cleared Sep 23, 1991
PROBE LATEX EXAMINATION GLOVES - STERILE
K912392 · LYY
Glovetex Industries
General Hospital · 143d
Cleared Sep 23, 1991
ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM
K912420 · HSB
Scientific Research
Orthopedic · 115d
Cleared Sep 23, 1991
SEVACARE STERILE SURGEON'S GLOVES
K912478 · KGO
Sevaids Industries
General Hospital · 112d
Cleared Sep 23, 1991
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
K912749 · MSJ
Medical Analysis Systems, Inc.
Immunology · 94d
Cleared Sep 23, 1991
XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL
K912753 · GCX
Xomed-Treace, Inc.
General Hospital · 91d
Cleared Sep 23, 1991
AMPLANTZ AND BENTSON GUIDEWIRES
K912798 · DQX
Meadox Medicals, Div. Boston...
Cardiovascular · 90d
Cleared Sep 23, 1991
CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY
K912833 · DSK
Camino Laboratories, Inc.
Cardiovascular · 89d
Cleared Sep 23, 1991
PROFUSE INFUSION SYSTEM
K912877 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 84d