Search FDA 510(k) Database

7,095 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20521–20544 of 174,061
Cleared Aug 20, 2019
Exactech Equinoxe Humeral Augmented Trays
K191561 · PHX
Exactech, Inc.
Orthopedic · 68d
Cleared Aug 20, 2019
iNSitu Total Hip System
K191936 · LPH
Thecken Companies, LLC
Orthopedic · 32d
Cleared Aug 19, 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical...
K183356 · FRG
Weihai Xingtai Packaging Products...
General Hospital · 258d
Cleared Aug 19, 2019
Blood Pressure Monitor
K190207 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 196d
Cleared Aug 19, 2019
Zavation eZspand Interbody System
K191339 · MAX
Zavation Medical Products, LLC
Orthopedic · 91d
Cleared Aug 19, 2019
CrossRoads Screw System
K191342 · HWC
Crossroads Extemity Systems, LLC
Orthopedic · 91d
Cleared Aug 19, 2019
Optilite IgA Kit
K191985 · CFN
The Binding Site Group , Ltd.
Immunology · 25d
Cleared Aug 16, 2019
Combined Aerobika OPEP and VersaPAP device
K183108 · BWF
Trudell Medical International
Anesthesiology · 281d
Cleared Aug 16, 2019
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K183536 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 240d
Cleared Aug 16, 2019
TriMAX Implant System
K190722 · JDR
Crossroads Extemity Systems, LLC
Orthopedic · 149d
Cleared Aug 16, 2019
EQ Balance
K190735 · LXV
Upright Science, Inc.
Ear, Nose, Throat · 148d
Cleared Aug 16, 2019
Vyntus BODY
K190853 · BZC
Vyaire Medical, Inc.
Anesthesiology · 136d
Cleared Aug 16, 2019
GIM-STIM OTC TENS/EMS System
K190988 · NUH
Gemore Technology Co, Ltd.
Neurology · 123d
Cleared Aug 16, 2019
Piezon Built-in Kit, Piezon Built-in Kit LED
K191079 · ELC
E.M.S Electro Medical Systems S.A
Dental · 115d
Cleared Aug 16, 2019
980nm Diode Laser Therapy Device
K191349 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 88d
Cleared Aug 16, 2019
PowerDR
K191504 · JAA
Radiology Information Systems, Inc.
Radiology · 71d
Cleared Aug 16, 2019
Tria Soft Ureteral Stent
K191609 · FAD
Boston Scientific Corporation
Gastroenterology & Urology · 60d
Cleared Aug 16, 2019
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · JFP
Nova Biomedical Corporation
Chemistry · 59d
Cleared Aug 16, 2019
APTUS Foot System
K191636 · JDR
Medartis AG
Orthopedic · 58d
Cleared Aug 16, 2019
SKR 4000
K191645 · MQB
Konica Minolta, Inc.
Radiology · 58d
Cleared Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro...
K191899 · CFR
Roche Diagnostics
Chemistry · 31d
Cleared Aug 16, 2019
SAFECARE® THC Urine Strip Test
K191924 · NFW
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 29d
Cleared Aug 16, 2019
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT...
K191933 · HQC
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 28d
Cleared Aug 16, 2019
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS...
K192018 · ODP
Titan Spine, Inc.
Orthopedic · 18d