16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SMITHWICK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
ROLLO 216X60X16E.NK(BARASHEED
FDA UDI
AB MEDICA GROUP, S.A.·08428763005872·
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828135771·GEN4 Direct Access
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828106399·GEN4 Direct Access
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000307·1.6mm x 8mm OMI Orthodontic Anchor Screw
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
BLAINE SCARCARE PATCH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Acapella One
FDA UDI
Choice Spine, LP·10885862244888·
AUTO ENDO5 ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·August 8, 2017
SULOX, HEAD, L, 32/+3.5, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWA·August 29, 2023
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 21, 2011
CANNULATED AWL
FDA Adverse Event
Malfunction
·EBI·Product code HWJ·March 25, 2008
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018