18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIGECYCLINE 15UG BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
SCITON IMAGE HAIR REMOVAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMART GLOVE STERILE NITRILE EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
TMJ CONCEPTS
FDA Adverse Event
TMJ CONCEPTS·Product code LZD·April 5, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·May 27, 2008
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 7, 2011
COMP RVS CNTRL SCR 6.5X45MM ST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
COMP NON-LCKNG SCREW 4.75X35MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
COMP LOCKING SCREW 4.75X30MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
COMP RVRS SHLDR GLNSP STD 41MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
COMP NON-LCKNG SCREW 4.75X40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
COMP NON-LCKNG SCREW 4.75X40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
COMP LOCKING SCREW 4.75X25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 14, 2022
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024