15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPI CONTACT PLATFORM O 4.0 MM
FDA 510(k)
FDA Class 2
·Dental
Phonak
FDA UDI
Phonak AG·07612847986053·Naída S CRT III (light pink)
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
NIM TRIVANTAGE EMG TUBE, 7MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·April 23, 2013
BD
FDA Adverse Event
Malfunction
·BECTON DICKINSON DIVISION·Product code FMF·April 1, 2011
CAPSURE Z
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 14, 2021
BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 25, 2023
BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 25, 2023
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·October 7, 2020
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
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