15 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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syngo.CT Skull Unfolding
FDA 510(k)
FDA Class 2
·Radiology
XLP - Toyota - Black - XLPouch
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030111·XLP - Toyota - Black - XLPouch
RR - UP - Commuter Passenger - zlb
FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036876·Trial Rasp, No Stop, Assembly, Lordotic, 11mm
ELECSYS TESTOSTERONE CALSET II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STEELEX STERNUM SET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
20 G X .32 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 21, 2017
IAB: 8 FR - 30 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·October 17, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 2, 2013
22 G X .25 MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·March 12, 2017
ANTI-A (MURINE MONOCLONAL) SERIES 1
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·April 18, 2012
PERSONA HEX HEADED SCREW 3.5 MM HEX 27 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LXH·April 10, 2025
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
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024