Search FDA 510(k) Database

7,047 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19681–19704 of 174,061
Cleared Nov 27, 2019
Multi-modality workstation
K192519 · ONF
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 75d
Cleared Nov 27, 2019
Diagnostic Ultrasound System
K192791 · IYO
Edan Instruments, Inc.
Radiology · 58d
Cleared Nov 27, 2019
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
K192945 · HAW
7D Surgical, Inc.
Neurology · 40d
Cleared Nov 26, 2019
TRAUS Dental Handpieces
K182892 · EGS
Saeshin Precision Co., Ltd.
Dental · 407d
Cleared Nov 26, 2019
Physica KR Liner and SMR Reverse Humeral Liner
K190911 · JWH
Limacorporate
Orthopedic · 232d
Cleared Nov 26, 2019
FiberTak Button
K191426 · MBI
Arthrex, Inc.
Orthopedic · 181d
Cleared Nov 26, 2019
Heraeus Peripheral Guidewire
K191502 · DQX
Heraeus Medical Components, LLC
Cardiovascular · 173d
Cleared Nov 26, 2019
OrthoGold
K191961 · PZL
Tissue Regeneration Technologies
General & Plastic Surgery · 126d
Cleared Nov 26, 2019
Peridot Intervertebral body fusion System
K192026 · MAX
Gbs Commonwealth Co., Ltd.
Orthopedic · 120d
Cleared Nov 26, 2019
Access PCT, Access PCT Calibrators
K192271 · PTF
Beckman Coulter, Inc.
Microbiology · 96d
Cleared Nov 26, 2019
HealthCXR
K192320 · QFM
Zebra Medical Vision, Ltd.
Radiology · 92d
Cleared Nov 26, 2019
Ion Endoluminal System
K192367 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 88d
Cleared Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
K192376 · PGI
Diasorin Molecular, LLC
Microbiology · 88d
Cleared Nov 26, 2019
Streamline MIS Spinal Fixation System
K192396 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 84d
Cleared Nov 26, 2019
ARIX Cannulated Screw System
K192417 · HWC
Jeil Medical Corporation
Orthopedic · 83d
Cleared Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738 · JWY
Biomerieux S.A.
Microbiology · 60d
Cleared Nov 26, 2019
DePuy Synthes Trauma Screws
K192745 · HWC
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 57d
Cleared Nov 26, 2019
NeuroOne Cortical Electrode
K192764 · GYC
Neuroone, Inc.
Neurology · 57d
Cleared Nov 26, 2019
Advocate PTA Catheter
K192907 · LIT
Merit Medical Systems, Inc.
Cardiovascular · 42d
Cleared Nov 26, 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
K192919 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Nov 26, 2019
DePuy Corail AMT Hip Prosthesis
K192946 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 39d
Cleared Nov 25, 2019
Pivot System Sterilization case
K181845 · KCT
Rp Medical, Inc.
General Hospital · 502d
Cleared Nov 25, 2019
Infant Incubator
K190494 · FMZ
Ningbo David Medical Device Co., Ltd.
General Hospital · 270d
Cleared Nov 25, 2019
SOZO
K190529 · QJB
ImpediMed Limited
Gastroenterology & Urology · 266d