12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLAVIS
FDA 510(k)
FDA Class 2
·Anesthesiology
BHR MODULAR HEAD 46MM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code KWY·January 4, 2018
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
56MM AND R3 ACETABULAR SHELL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018
STONEBREAKER SINGLE USE PROBE
FDA Adverse Event
Malfunction
·COOK INC·Product code FFK·March 28, 2018
THORACIC PEDICLE PROBE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 17, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·April 19, 2011
UNKNOWN DEPUY CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·June 17, 2008
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
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