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
113497–113520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1993
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K920178 · DTN
Lifestream Int'L, Inc.
Cardiovascular · 485d
Cleared May 13, 1993
IRRIGATION PUMPS AND TUBING AND SUCTION TUBING
K921457 · GCJ
American Surgical Instruments Corp.
General & Plastic Surgery · 413d
Cleared May 13, 1993
SILENT SCAN
K921891 · LNH
Avotec, Inc.
Radiology · 386d
Cleared May 13, 1993
LATEX EXAMINATION GLOVES
K922439 · LYY
Transcorp
General Hospital · 356d
Cleared May 13, 1993
FLO-GARD 2100 - 2M8281M
K923066 · LZH
Baxter Healthcare Corp
General Hospital · 322d
Cleared May 13, 1993
NEEDLELESS INJECTION CANNULA
K923653 · LJS
Arrow Intl., Inc.
General Hospital · 296d
Cleared May 13, 1993
SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS
K923875 · FRN
I-Flow Corp.
General Hospital · 283d
Cleared May 13, 1993
SYSTEM 7500 NIBP/SA02
K924910 · DXN
Advanced Medical Instruments, Inc.
Cardiovascular · 226d
Cleared May 13, 1993
BIRD 1000 PV PORTABLE VENTILATOR
K925422 · CBC
Bird Products Corp.
General Hospital · 198d
Cleared May 13, 1993
POWDER-FREE LATEX EXAMINATION GLOVES
K925537 · LYY
Safetytech Sdn. Bhd.
General Hospital · 192d
Cleared May 13, 1993
VIDAS THYROXINE (T4) ASSAY (T4)
K926393 · KLI
Biomerieux Vitek, Inc.
Chemistry · 143d
Cleared May 13, 1993
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
K930798 · DXN
Omron Healthcare, Inc.
Cardiovascular · 86d
Cleared May 13, 1993
STAODYN MAXIMA III
K930865 · GZJ
Staodyne, Inc.
Neurology · 84d
Cleared May 13, 1993
RASCAL II
K930866 · CCK
Ohmeda Medical
Anesthesiology · 83d
Cleared May 13, 1993
PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION
K931147 · MHI
Alexon, Inc.
Microbiology · 69d
Cleared May 13, 1993
MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPIC
K931276 · GCJ
Minimally Invasive Surgical...
General & Plastic Surgery · 66d
Cleared May 13, 1993
MILLIPORE RT-100 AEROSOL RETENTION FILTER
K931603 · CAF
Sterimatics Co.
Anesthesiology · 42d
Cleared May 12, 1993
THREADED PINS
K920188 · MBJ
Kirschner Medical Corp.
Orthopedic · 483d
Cleared May 12, 1993
BIOMETRIC SCREW FIXATION CUP
K922861 · JDL
Osteo Technology, Inc.
Orthopedic · 342d
Cleared May 12, 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · KGX
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 315d
Cleared May 12, 1993
CONTACT LENS CASE
K923458 · LRX
Nomax, Inc.
Ophthalmic · 302d
Cleared May 12, 1993
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
K923869 · JDQ
Codman & Shurtleff, Inc.
Orthopedic · 282d
Cleared May 12, 1993
NK GRASP SENSOR, MODEL GA001
K923964 · LBB
Nk Biotechnical Engineering Co.
Neurology · 278d
Cleared May 12, 1993
NK GRASP SENSOR, MODEL GA002
K923965 · LBB
Nk Biotechnical Engineering Co.
Neurology · 278d