14 results
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23ms
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Sources: EU EUDAMED, US FDA
ARGYLE COMPACT CHEST DRAINAGE SYS.
FDA 510(k)
FDA Class 2
·General Hospital
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113448·SUPER SHARPS 15 DEG 3MM (BX/5)
Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
STERILE SPONGE BOWLS
FDA 510(k)
FDA Class 1
·General Hospital
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 18, 2012
NEXGEN STEMMED TIBIAL BROACH IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LXH·February 21, 2014
LDR SPINE ROI-A INTERBODY FUSION DEVICE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code MAX·August 6, 2010
BIOMET VANGUARD PATELLA COMPONENTS
FDA Adverse Event
Injury
·.·Product code JWH·July 13, 2017
BIOMET VANGUARD COMPLETE KNEE SYSTEM TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 12, 2017
BIOMET REGENEREX TIBIAL COMPONENTS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·July 13, 2017
BIOMET MCK MAXIMUM CONGRUENT KNEE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 12, 2017
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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