FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37729–37752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2014
NEURODYN COMPACT, NEURODYN II
K131917 · IPF
Ibramed Equipamentos Medicos
Physical Medicine · 307d
Cleared Apr 29, 2014
ELECTRIC HANDPIECE SYSTEM
K132570 · EBW
Ttbio Corp.
Dental · 257d
Cleared Apr 29, 2014
NEUROMATE FRAMELESS GEN II
K132755 · HAW
Renishaw Mayfield Sarl
Neurology · 238d
Cleared Apr 29, 2014
ORIGIO(R) SEQUENTIAL BLAST TM
K133387 · MQL
Origio A/S
Obstetrics & Gynecology · 175d
Cleared Apr 29, 2014
ACCU-CHEK AVIVA PLUS SYSTEM
K133862 · NBW
Roche Diagnostics Corporation
Chemistry · 131d
Cleared Apr 29, 2014
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K133879 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 130d
Cleared Apr 29, 2014
NEW STETIC DENTAL AMALGAM ALLOY
K140125 · OIV
New Stetic
Dental · 103d
Cleared Apr 29, 2014
COMFORTSOFT SOFT DENTURE LINER SYSTEM
K140146 · EBI
Whip-Mix Corp.
Dental · 97d
Cleared Apr 29, 2014
GENERAL SPINAL SYSTEM
K140229 · MNI
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 89d
Cleared Apr 29, 2014
FAMILY OF DISPOSABLE LENSES
K140368 · HKS
Sensor Medical Technology, LLC
Ophthalmic · 74d
Cleared Apr 28, 2014
SPLIT CATH RG
K130889 · MSD
Medcomp
Gastroenterology & Urology · 395d
Cleared Apr 28, 2014
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
K132042 · HOY
X6d, Ltd.
Ophthalmic · 300d
Cleared Apr 28, 2014
ARASYS
K132179 · NGX
Ion Genius, Inc.
Physical Medicine · 287d
Cleared Apr 28, 2014
ACESSA GUIDANCE HANDPIECE
K132184 · HFG
Halt Medical, Inc.
Obstetrics & Gynecology · 287d
Cleared Apr 28, 2014
OPTEO, VIDEOGRAPH HD
K133271 · MUH
Owandy
Radiology · 186d
Cleared Apr 28, 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD...
K133537 · LFR
Eps Bio Technology Corp.
Chemistry · 161d
Cleared Apr 28, 2014
PURACYN PLUS SKIN AND WOUND
K133542 · FRO
Innovacyn, Inc.
General & Plastic Surgery · 161d
Cleared Apr 28, 2014
ARTIS ONE
K133580 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 158d
Cleared Apr 28, 2014
GSP NEONATAL TOTAL GALACTOSE KIT
K133652 · JIA
Wallac Oy, A Subsidiary of...
Chemistry · 152d
Cleared Apr 28, 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 152d
Cleared Apr 28, 2014
EMPRINT ABLATION SYSTEM
K133821 · NEY
Covidien, LLC
General & Plastic Surgery · 133d
Cleared Apr 28, 2014
BRELLA-SPEC(TM) VAGINAL SPECULUM
K133857 · HIB
Proa Medical, Inc.
Obstetrics & Gynecology · 130d
Cleared Apr 28, 2014
SUCTION PUMP
K140031 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 112d
Cleared Apr 28, 2014
XENMATRIX SURGICAL GRAFT
K140501 · FTM
C. R. Bard
General & Plastic Surgery · 60d