11 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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FreeStyle Libre 3 Continuous Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PANALOK QUICKANCHOR ETHIBOND
FDA UDI
DEPUY MITEK, LLC·10886705001965·PANALOK RC QUICKANCHOR PLUS (DS) Dual Suture (D...
CHESAPEAKE® Stabilization System
FDA UDI
VB Spine LLC·10888857081994·2-Screw Titanium Implant, Size 13x18x12 mm
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 29, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 8, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 9, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024