15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm
TISSUELINK BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACT 11 MP VENTRICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·August 19, 2020
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM
FDA Adverse Event
Malfunction
·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015
CAIMAN DISP INSTR ARTICULAT D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 16, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 3, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 5, 2014
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code MND·April 15, 2011
CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·April 26, 2005
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