21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
FDA 510(k)
FDA Class 2
·Anesthesiology
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
Excalibur Introducer System
FDA UDI
Bard Access Systems, Inc.·00801741074745·EXCALIBUR INTRO 2FR
NA
FDA UDI
GAMBRO DASCO SPA·07332414032531·SP-394 Accessory reinfusion line
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032403·PERSONALITY 70 SHEER, SIZE 4XXL, VISONE, GRADUA...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032403·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm B...
VANGUARD REPROCESSED COMPRESSION GARMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVOFINE 31 DISPOSABLE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017
ARCOM 26MM RINGLOC LINER HIWALL 22
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 3, 2013
SIG MOD TIB TRAY CEM COCR 4
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·March 28, 2011
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION FEMORAL NAIL
FDA Adverse Event
Malfunction
·ZIMMER MANUFACTURING B.V.·Product code JDS·April 17, 2008
Misys Laboratory versions 5.23 and 5.3 with Callback
FDA Recall
Terminated
·Sunquest Information Systems·Product code JQP·October 18, 2002
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
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 VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024