FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
30121–30144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2017
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
K163254 · HQD
Acuity Polymers, Inc.
Ophthalmic · 58d
Cleared Jan 18, 2017
NovaBone IRM
K163310 · MQV
Novabone Products, LLC
Orthopedic · 56d
Cleared Jan 18, 2017
Quantum Workstation
K163657 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 26d
Cleared Jan 17, 2017
Precision Thin Reciprocating Blade, 0.010in.
K161514 · EQJ
Stryker Corporation
Ear, Nose, Throat · 229d
Cleared Jan 17, 2017
Humelock Reversed Shoulder
K162455 · PHX
Fx Solutions
Orthopedic · 137d
Cleared Jan 17, 2017
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A...
K162663 · GZJ
Well-Life Healthcare Limited
Neurology · 113d
Cleared Jan 17, 2017
Chameleon PTA Balloon Catheter
K163231 · LIT
Av Medical Technologies, Ltd.
Cardiovascular · 61d
Cleared Jan 17, 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554 · KHE
Immunostics Inc.,
Hematology · 29d
Cleared Jan 13, 2017
Kolplast Cervical Sample Collection Kit
K153128 · HHT
Kolplast CI SA
Pathology · 442d
Cleared Jan 13, 2017
SuperLine
K160965 · DZE
Dentium Co., Ltd.
Dental · 282d
Cleared Jan 13, 2017
PANPAC DISPOSABLE VACUUM CURETTES
K161106 · HGH
Panpac Medical Corporation
Obstetrics & Gynecology · 269d
Cleared Jan 13, 2017
Cantab Mobile
K161328 · PKQ
Cambridge Cognition , Ltd., US Agent:...
Neurology · 246d
Cleared Jan 13, 2017
DynaMatrix/Dynamatrix Plus
K161762 · NPL
Cook Biotech Incorporated
Dental · 200d
Cleared Jan 13, 2017
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated...
K162164 · MVL
Kerr Corporation
Dental · 163d
Cleared Jan 13, 2017
RED Light Device
K162489 · OHS
Zhongshan Bisen Plastic Electronic...
General & Plastic Surgery · 128d
Cleared Jan 13, 2017
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 127d
Cleared Jan 13, 2017
Legion Cone System
K162775 · JWH
Smith & Nephew, Inc.
Orthopedic · 102d
Cleared Jan 13, 2017
OsteoVation Impact
K162864 · GXP
Skeletal Kinetics, LLC
Neurology · 92d
Cleared Jan 13, 2017
RX DC
K163519 · EHD
Cefla S.C.
Radiology · 29d
Cleared Jan 13, 2017
Lumipulse G FSH-N Calibrators
K163534 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 13, 2017
Magseed Magnetic Marker System
K163541 · PBY
Endomagnetics Ltd.,
General & Plastic Surgery · 28d
Cleared Jan 13, 2017
Lumipulse G Progesterone-N Calibrators
K163546 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 28d
Cleared Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
K161217 · LON
bioMerieux, Inc.
Microbiology · 258d
Cleared Jan 12, 2017
Meridian M110 Fetal Monitoring System
K161902 · HGM
Mindchild Medical
Obstetrics & Gynecology · 185d