14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743724·ACHIMED ACHILLES SUPP SAND III
Octane Straight
FDA UDI
Choice Spine, LP·10885862235947·
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278135·
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080228130·28mm x 13mm Non-Lordotic Spacer
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BACT/ALERT FA CULTURE BOTTLE
FDA 510(k)
FDA Class 1
·Microbiology
ZERONA ERCHONIA LASER SCANNER
FDA Adverse Event
ERCHONIA·Product code OLI·March 21, 2013
SIMILE
FDA Adverse Event
Injury
·PENTRON CLINICAL·Product code EBF·March 17, 2011
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 28, 2008
MS-30 STEM LATERAL POLISHED 6
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·December 17, 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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022