14 results
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18ms
·
Sources: EU EUDAMED, US FDA
BARRIER PLUS SURGEON GOWNS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CODMAN MALIS
FDA UDI
Cerenovus, Inc.·10886704035831·CODMAN MALIS Single Footpedal
ACUMED
FDA UDI
Acumed LLC·10806378047145·22mm SLIC Screw® Driver
GOLDFINGER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TEMPTOUCH DERMAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·October 23, 2012
ASAHI GAIA FIRST PRE-SHAPE
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·May 26, 2015
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026