17 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LODOX, MODEL BASELINE
FDA 510(k)
FDA Class 2
·Radiology
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547380·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547410·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547373·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547397·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547427·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547366·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033547403·
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
FDA 510(k)
FDA Class 2
·Cardiovascular
MetaSystems Probes
FDA UDI
MetaSystems Probes GmbH·04251315807051·XL MET amp, 10x 100µl
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 10, 2011
LIFEPAK 9 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·March 13, 2008
OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015