12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGIVISION INC. CLEARPOINT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015562·microSelectron Transfer Tube for 4F Flexibles (2)
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809282815744·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390864114·
CRYOPLAN SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMS AIR-FLOW MASTER PIEZON
FDA 510(k)
FDA Class 2
·Dental
MAXCEM ELITE
FDA Adverse Event
Malfunction
·KERR CORPORATION·Product code EMA·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
QUILL KNOTLESS TISSUE-CLOSURE DEVICE
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·May 20, 2011
4.5 BROAD SCP PLT 26-H STER
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024