13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·40649111170134·SURG BLADE CARBON STER #23/100
MultiStage®
FDA UDI
Dongguan TT Medical, Inc.·06934184004223·
COBE HC 700 MIDI HEMOCONCENTRATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 17, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 21, 2011
ZERO TIP NITINOL STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·June 19, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015