13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·May 9, 2014
PMMA disc
FDA UDI
Dentsply International Inc.·D00180826250·
Centaur Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126964·
METHAFILCON A
FDA 510(k)
FDA Class 2
·Ophthalmic
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
M-1 COT - BASE HIGH LOAD 28
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 29, 2013
RESERVOIR 3CC
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 27, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 25, 2008
CORIN METAFIX HIP STEM
FDA Adverse Event
Injury
·CORIN MEDICAL·Product code LZO·September 6, 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018