20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CYTOASPIRATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227958·BOSS Detach Myringotomy Bld
FLUID-FILLED TEETHER
FDA 510(k)
FDA Class 2
·Dental
HOLY DRAGON ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·TENEX HELTH·Product code LFL·February 24, 2014
MOOG CURLIN 1.2 MICRO IV TUBING SET 340-4128
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES·Product code FPA·November 12, 2010
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 30, 2012
VANGUARD 360 REVISION SYSTEM SSK/DA 360 DISTAL FEMORAL AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
BIOMET SPLINED KNEE STEM V2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
VANGUARD 360 REVISION SYSTEM SSK/DA 360 POSTERIOR AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
BIOMET 360 OFFSET ADAPTOR WITH SCREWS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
VANGUARD SSK 360/DA360 KNEE SYSTEM FEMORAL RIGHT - WITH SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
VANGUARD 360 KNEE STYSTEM OSSEOTI TIBIAL SLEEVE AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·March 27, 2019
BIOMET 360 TIBIAL TRAY WITH TI LOCKING BAR & SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
VANGUARD(TM) DCM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
VANGUARD 360 REVISION SYSTEM SSK/DA 360 DISTAL FEMORAL AUGMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
BIOMET SPLINED KNEE STEM V2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 27, 2019
BIOMET SPLINED KNEE STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 10, 2017
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