15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
FDA 510(k)
FDA Class 2
·Anesthesiology
ACTIVELIFE
FDA UDI
CONVATEC, PURCHASING DEPARTMENT·00768455101429·Activelife® One-Piece Pre-Cut Drainable Pouch W...
WU HO MEDICAL INSTRUMENTS MFG. CO. LTD.
FDA registration
WU HO MEDICAL INSTRUMENTS MFG. CO. LTD.·12 products·🇹🇼 Taiwan
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·November 20, 2018
BAYONET FORCEPS BIPOLAR IRRIGATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STRATA II VALVE, SMALL
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·March 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 17, 2011
CONSTRAINED ACETABULAR INSERTS
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWB·March 31, 2008
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
ASAHI PROWATER
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019
TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·February 21, 2019
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018