Search FDA 510(k) Database

7,156 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22321–22344 of 174,061
Cleared Dec 21, 2018
DIO CAD/CAM Abutment
K181037 · NHA
Dio Corporation
Dental · 246d
Cleared Dec 21, 2018
2.8 mm/3.3 mm PopLok Suture Anchors
K181120 · MBI
Conmed Corporation
Orthopedic · 238d
Cleared Dec 21, 2018
JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
K181331 · EBI
Juvora, Ltd.
Dental · 214d
Cleared Dec 21, 2018
VITEK MS
K181412 · QBN
bioMerieux, Inc.
Microbiology · 205d
Cleared Dec 21, 2018
Arthrex Fracture Adapter Hemi Shoulder Prosthesis
K181555 · KWS
Arthrex, Inc.
Orthopedic · 191d
Cleared Dec 21, 2018
Clear-Jet Injection Catheter
K181690 · FBK
Finemedix Co., Ltd.
Gastroenterology & Urology · 178d
Cleared Dec 21, 2018
Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS...
K181752 · HRX
Stryker Corporation
Orthopedic · 172d
Cleared Dec 21, 2018
ADVIA Centaur Calcitonin (CALCT) assay
K182012 · JKR
Axis-Shield Diagnostics Limited
Chemistry · 147d
Cleared Dec 21, 2018
SterilContainer S System
K182032 · KCT
Aesculap, Inc.
General Hospital · 144d
Cleared Dec 21, 2018
The ICHOR Panacea Vascular Embolectomy Catheter System
K182167 · QEW
Ichor Vascular, Inc.
Cardiovascular · 133d
Cleared Dec 21, 2018
OrthoGold 100
K182682 · ISA
Tissue Regeneration Technologies
Physical Medicine · 86d
Cleared Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K182690 · PEO
Genmark Diagnostics, Incorporated
Microbiology · 85d
Cleared Dec 21, 2018
4D View
K182750 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared Dec 21, 2018
Disposable Temperature Probe
K182755 · FLL
Shenzhen Caremed Medical Technology...
General Hospital · 84d
Cleared Dec 21, 2018
Neocis Guidance System
K182776 · PLV
Neocis, Inc.
Dental · 81d
Cleared Dec 21, 2018
PTS Professional Chemistry Kit
K182781 · CGA
Polymer Technology Systems, Inc....
Chemistry · 81d
Cleared Dec 21, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795 · OOE
Lensar, Inc.
Ophthalmic · 81d
Cleared Dec 21, 2018
vascuCAP
K183012 · LLZ
Elucid Bioimaging, Inc.
Radiology · 51d
Cleared Dec 21, 2018
3nethra neo
K183059 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 21, 2018
Nitrile Glove Powder Free White
K183068 · LZA
Haining Medical Products Co., Ltd.
General Hospital · 46d
Cleared Dec 21, 2018
Pulse Rx 2.0, Pulse Pro Rx 2.0
K183328 · JOW
NormaTec Industries, LP
Cardiovascular · 21d
Cleared Dec 20, 2018
AirSpiral Heated Breathing Tube
K162553 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 828d
Cleared Dec 20, 2018
3DIEMME RealGUIDE
K173041 · LLZ
3Diemme , Ltd.
Radiology · 448d
Cleared Dec 20, 2018
Natureplex Warm Touch Warming Jelly
K180828 · NUC
Natureplex, LLC
Obstetrics & Gynecology · 265d