11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mini Master Series Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746070938·1 PAT SETUP MINI MS MBT 022 U/L 6X6 IFIT W/HK 3...
P. GOPALDAS LTD.
FDA registration
P. GOPALDAS LTD.·2 products·🇨🇳 China
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
FDA 510(k)
FDA Class 2
·Hematology
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·September 7, 2021
PROPAQ MD DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code LDD·March 13, 2013
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·April 6, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·May 9, 2008
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
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