19 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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EBI P148 SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMDS Hybrid Prosthesis ("AMDS")
FDA UDI
Artivion, Inc.·00877234001222·55mm – 40mm Tapered Stent (32mm collar)
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136209·Ti-6Al-4V ALIF Implant 42 X 32, 15mm Height 7° ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136186·Ti-6Al-4V ALIF Implant 42 X 32, 11mm Height 7° ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136216·Ti-6Al-4V ALIF Implant 42 X 32, 17mm Height 7° ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136193·Ti-6Al-4V ALIF Implant 42 X 32, 13mm Height 7° ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523136223·Ti-6Al-4V ALIF Implant 42 X 32, 19mm Height 7° ...
INPULSE DENTAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
FDA 510(k)
FDA Class 2
·General Hospital
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·April 2, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 28, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG
FDA Adverse Event
Malfunction
·COSTA RICA·Product code LTI·April 18, 2008
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016