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
89449–89472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981076 · DYF
Impra, Inc.
Cardiovascular · 44d
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · DSY
Impra, Inc.
Cardiovascular · 44d
Cleared May 07, 1998
CARESIDE GLUCOSE
K981183 · CGA
Exigent Diagnostics, Inc.
Chemistry · 36d
Cleared May 07, 1998
GLU
K981185 · CFR
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
URIC ACID
K981189 · CDO
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR
K981305 · JIX
Olympus America, Inc.
Chemistry · 27d
Cleared May 07, 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · CAD
Draeger Medical, Inc.
Anesthesiology · 13d
Cleared May 07, 1998
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
K981474 · JJY
Spectral Diagnostics, Inc.
Chemistry · 13d
Cleared May 06, 1998
DIFFUSION PACKAGE / GYROSCAN NT
K973658 · LNH
Philips Medical Systems North...
Radiology · 223d
Cleared May 06, 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246 · HKI
Canon USA, Inc.
Ophthalmic · 103d
Cleared May 06, 1998
ECHOTECH 3D FREESCAN
K980308 · IYO
Echotech 3D Imaging Systems GmbH
Radiology · 99d
Cleared May 06, 1998
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K980444 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K980445 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
K980462 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K980463 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
QUICK-CUT AUTOMATIC BIOPSY SYSTEM
K980479 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 89d
Cleared May 06, 1998
CHARGER (ED)
K980567 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 82d
Cleared May 06, 1998
VSS, VIRTUAL SIMULATION SYSTEM
K980629 · IYE
Nucletron Corp.
Radiology · 77d
Cleared May 06, 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE...
K980646 · MQM
Instrumentation Laboratory CO
Chemistry · 76d
Cleared May 06, 1998
VR NETSERVE
K980684 · LMD
I.S.G. Technologies, Inc.
Radiology · 72d
Cleared May 06, 1998
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
K980715 · KPS
Adac Laboratories
Radiology · 71d
Cleared May 06, 1998
XTEND
K980752 · LKY
Walling Medical Equipment Co.
Gastroenterology & Urology · 75d
Cleared May 06, 1998
FACTS MONOBLOCK
K981267 · IZX
Dynarad Corp.
Radiology · 29d