17 results
·
26ms
·
Sources: EU EUDAMED, US FDA
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
FDA 510(k)
FDA Class 2
·Neurology
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659180659·Semi-tubular plates,87mm/5 holes _x000D_...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100070·Caddie, Implants and Instruments
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100070·Probe, Steffee Long Str Modular Qtr Sq
Semi-tubular plates,87mm/5 holes
FDA UDI
mahe medical gmbh·EMAH00200100870·Semi-tubular plates,87mm/5 holes
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0100010·Caddie, Common Plates and Screws
PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
FDA 510(k)
FDA Class 2
·General Hospital
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·November 20, 1997
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
GO BED PLUS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 1, 2011
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013