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
36409–36432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2014
WAVELIGHT FS200 LASER SYSTEM
K141476 · OOE
Alcon Research, Ltd. Dba Alcon...
Ophthalmic · 118d
Cleared Sep 30, 2014
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K141547 · DQY
Reflow Medical
Cardiovascular · 111d
Cleared Sep 30, 2014
FUSE COLONOSCOPY SYSTEM
K141598 · FDF
Endochoice, Inc.
Gastroenterology & Urology · 109d
Cleared Sep 30, 2014
CLAVEGUARD FREEDOM SURGICAL LIGHT
K142076 · FSY
Dickson & Dickson Healthcare (Us), Inc.
General & Plastic Surgery · 61d
Cleared Sep 30, 2014
ESOPHYX2 HD
K142113 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 30, 2014
PolyCatch Retrieval Device
K142258 · FDI
Medi-Globe Corporation
Gastroenterology & Urology · 47d
Cleared Sep 29, 2014
HELICAL RIDGE PEEK INTERFERENCE SCREW
K141290 · HWC
MedShape, Inc.
Orthopedic · 133d
Cleared Sep 29, 2014
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
K141314 · OVE
Spineart
Orthopedic · 132d
Cleared Sep 29, 2014
PRO-PICC WITH VALVE TECHNOLOGY
K141633 · LJS
Medical Components, Inc.
General Hospital · 103d
Cleared Sep 29, 2014
IMACOR ZURA EVO IMAGING SYSTEM
K142054 · IYO
Imacor, Inc.
Radiology · 62d
Cleared Sep 29, 2014
Operating Room Light Handle Adapter
K142386 · FTA
Litex Manufacturing, Inc.
General & Plastic Surgery · 33d
Cleared Sep 26, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K131817 · LNS
Osmunda Medical Device Consulting...
Gastroenterology & Urology · 463d
Cleared Sep 26, 2014
CLYDESDALE(R) SPINAL SYSTEM
K133577 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 309d
Cleared Sep 26, 2014
MEDLINE NEURO SPONGE
K140369 · HBA
Medline Industries, Inc.
Neurology · 224d
Cleared Sep 26, 2014
OPERA SWING
K140380 · JAA
General Medical Merate S.P.A
Radiology · 224d
Cleared Sep 26, 2014
SINGLE-SITE WRISTED NEEDLE DRIVER
K141075 · NAY
Intuitive Surgical
General & Plastic Surgery · 154d
Cleared Sep 26, 2014
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE
K141097 · GDW
Touchstone International Medical...
General & Plastic Surgery · 151d
Cleared Sep 26, 2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
K141113 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 149d
Cleared Sep 26, 2014
AERODR SYSTEM 2
K141271 · MQB
Konica Minolta, Inc.
Radiology · 134d
Cleared Sep 26, 2014
PROVOX FREEHANDS FLEXIVOICE
K141380 · EWL
Atos Medical AB
Ear, Nose, Throat · 122d
Cleared Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490 · JAQ
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Sep 26, 2014
PERFRACTION
K141800 · IYE
Sun Nuclear Corporation
Radiology · 85d
Cleared Sep 26, 2014
PRO-LINK WEDGE SYSTEM
K141905 · HRS
Life Spine
Orthopedic · 73d
Cleared Sep 26, 2014
STRYKER S2 DRILL
K141935 · ERL
Stryker Corporation
Ear, Nose, Throat · 71d