14 results
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28ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
FDA 510(k)
FDA Class 2
·Neurology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530451·
Lance Drill
FDA UDI
BIO CONCEPT Co., Ltd.·06947600302599·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845228·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE EXTRA ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450334218·
MICRORUPTER V
FDA 510(k)
FDA Class 2
·Ophthalmic
HA-TI (HAND TITANIUM SCREW) IMPLANT
FDA 510(k)
FDA Class 2
·Dental
HAHN TAPERED IMPLANT Ø4.3 X 11.5 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 15, 2021
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 11, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code LFR·May 30, 2008
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011
TEXIUM CLOSED MALE LUER WITH FEMAILE CAP
FDA Adverse Event
Malfunction
·CAREFUSION NORTH CAROLINA·Product code FPA·July 6, 2020
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
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