12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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K-Y BRAND ULTRA GEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Safco NiTi RL Rotary Files
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310208273·Safco NiTi RL rotary files, #25, (0.4 taper / 2...
EECP THERAPY SYSTEM, MODEL TS3
FDA Adverse Event
Injury
·VASOMEDICAL, INC.·Product code DRN·December 30, 2002
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
FDA 510(k)
FDA Class 2
·Orthopedic
MAC ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
VANGUARD PFR FEMORAL LT SM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018
TRIDENT 0 DEG INSERT 40MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·August 25, 2017
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
4.5MM HEX ADJ SCREWDRIVER BLADE W/SPADE POINT HXC
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·March 26, 2013
CE INTERMATE LV167,24 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 16, 2011
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