24 results
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30ms
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Sources: EU EUDAMED, US FDA
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bard Poly Midline
FDA UDI
Bard Access Systems, Inc.·00801741137464·Catheter Placement Kit
Bard Tri-Funnel Replacement Gastrostomy Tube
FDA UDI
Bard Access Systems, Inc.·00801741037139·Bard Tri-Funnel Replacement Gastrostomy Tube 16F
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282506131·TeWa PJ-Type 1830: coated acupuncture needles ...
TEWA
FDA UDI
asia-med GmbH·04251282513122·TeWa PJ-Type 1830: coated acupuncture needles ...
Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®
FDA UDI
I.C. MEDICAL, INC.·00817688024309·Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond...
SOLACE Sacroiliac Fixation System
FDA UDI
XENIX MEDICAL LLC·00818345029361·Pin to pin connector, 16mm
Cohere
FDA UDI
VERTERA, INC.·B14210000007160·COHERE Cervical cage, 14x16x7MM with 7o Lordosis
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 23, 2024
BARCOMED 5MP2
FDA 510(k)
FDA Class 2
·Radiology
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·February 25, 2025
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 15, 2024
PTERYFIT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 14, 2024
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·March 12, 2013
PRISM HIV O PLUS
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MZF·February 24, 2011
INDURA
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LKK·February 15, 2008
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·January 13, 2022
qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 28, 2012