16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COMFORT WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
APC™ II Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221061829·Mini Uni-Twin(TM) Bracket APC(TM) II LL3 -7T/6A...
APC™ PLUS Unitek™ Mini Uni-Twin
FDA UDI
3M UNITEK CORPORATION·00652221092847·Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL3 -7T/...
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717104466·Stainless Steel H Files (Hand), Size # 55, Leng...
3M™ Unitek™ Uni-Twin™
FDA UDI
3M UNITEK CORPORATION·00652221015914·Mini Uni-Twin(TM) Bracket LL3 -7T/6A .018 5/Pk
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO: PRONTO DRY
FDA 510(k)
FDA Class 1
·Microbiology
FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·July 2, 2019
SHELL POROUS WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·July 2, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 16, 2011
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE -
FDA Adverse Event
Injury
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GDW·March 5, 2008
REFLEX CATHETER
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·March 18, 2025
LOTUS EDGE VALVE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NPT·December 5, 2020
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