17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RM BOND, MODEL J032
FDA 510(k)
FDA Class 2
·Dental
PELVIC MUSCLE THERAPY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LERMAN & SON CRANIAL ORTHOSIS HELMET
FDA 510(k)
FDA Class 2
·Neurology
UNK CONSTRAINED LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 27, 2018
COCR MODULAR HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 27, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 27, 2025
EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 25, 2022
TAPERLOC POR RED/DIST 13.5X147
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018
32MM MOD HEAD COCR -6MM NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018
ADVANTAGE FIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code FTL·April 17, 2013
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 31, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·July 10, 2008
TAPERLOC POR RED/DIST 13.5X147
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018
32MM MOD HEAD COCR -6MM NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 26, 2018
XP-XP Tibial Tray - Interlok 65 mm Item # 195752
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015