Search FDA 510(k) Database

7,067 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20041–20064 of 174,061
Cleared Oct 18, 2019
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
K191943 · OLO
Medos International SARL
Orthopedic · 88d
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325 · LGZ
Life Warmer, Inc.
General Hospital · 52d
Cleared Oct 18, 2019
Confirm Rx Insertable Cardiac Monitor
K192593 · MXC
Abbott
Cardiovascular · 28d
Cleared Oct 18, 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
K192598 · QEY
Thrombolex, Inc.
Cardiovascular · 28d
Cleared Oct 18, 2019
NuVasive Modulus XLIF Interbody System
K192760 · MAX
Nu Vasive, Incorporated
Orthopedic · 18d
Cleared Oct 17, 2019
BcSs-PICNI-2000 Sensor
K182073 · GWM
Braincare Desenvolvimento E Inovacao...
Neurology · 442d
Cleared Oct 17, 2019
EasyMark Tissue Marker
K183503 · NEU
Inrad, Inc.
General & Plastic Surgery · 304d
Cleared Oct 17, 2019
DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System,...
K190102 · DXT
Osprey Medical, Inc.
General Hospital · 268d
Cleared Oct 17, 2019
SmartCeph
K190162 · LLZ
Ortho2, LLC
Radiology · 259d
Cleared Oct 17, 2019
Voxel Dosimetry™ v1.0
K191216 · LLZ
Hermes Medical Solutions AB
Radiology · 164d
Cleared Oct 17, 2019
Freestyle Flex
K191653 · HGX
Medela AG
Obstetrics & Gynecology · 119d
Cleared Oct 17, 2019
MT One Diamond
K191942 · GEX
M&T S.R.L.
General & Plastic Surgery · 87d
Cleared Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
K192175 · NBW
ACON Laboratories, Inc.
Chemistry · 66d
Cleared Oct 17, 2019
WavelinQ Plus EndoAVF System
K192239 · PQK
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Oct 17, 2019
Matrix HA PEEK Cervical Implant System
K192316 · ODP
Sapphire Medical Group
Orthopedic · 52d
Cleared Oct 17, 2019
Arthrex SwiveLock Anchors
K192441 · MAI
Arthrex, Inc.
Orthopedic · 41d
Cleared Oct 17, 2019
Merge PACS
K192455 · LLZ
Merge Healthcare Incorporated
Radiology · 38d
Cleared Oct 17, 2019
Carnation Ambulatory Monitor
K192556 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 30d
Cleared Oct 17, 2019
Reach and CQ'ENCE Circular Staplers
K192566 · GDW
Reach Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 16, 2019
Pitkar External Fixation System
K190486 · KTT
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 230d
Cleared Oct 16, 2019
Arthrex Minimally Invasive Ankle Fusion Plate
K190953 · HRS
Arthrex, Inc.
Orthopedic · 188d
Cleared Oct 16, 2019
Ventripoint Medical System Plus (VMS+) 3.0
K191493 · LLZ
Ventripoint Diagnostics , Ltd.
Radiology · 133d
Cleared Oct 16, 2019
SECURE Screw
K191771 · HWC
A.M. Surgical, Inc.
Orthopedic · 106d
Cleared Oct 16, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K192250 · JWY
Thermo Fisher Scientific
Microbiology · 58d