20 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PERCUTANEOUS INTRODUCER KIT
FDA 510(k)
FDA Class 2
·General Hospital
VERTEX® Reconstruction System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902060427·CONNECTOR 6902135 LATERAL OPEN 10MM
OMEGA
FDA UDI
Stryker GmbH·07613154482566·Optional Instrument Tray
Fluid Retention Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227477·House Fcps, 6mm, side opning jaws
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981206185·Mariner 6.0 Tray, Insert 2
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889998163471·Mariner 6.0 Tray, Insert 2
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123816·K-WIRE - DOUBLE TROCAR 1.25mm DIA x 125mm
MODIFICATION TO IVENT 101
FDA 510(k)
FDA Class 2
·Anesthesiology
SLEEPSTRIP DISPOSABLE APNEA SCREENER
FDA 510(k)
FDA Class 2
·Anesthesiology
LINER: MPACT FLAT PE HC LINER Ø36/F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 31, 2020
CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·November 26, 2019
SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·September 5, 2019
SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LPH·August 9, 2019
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·Product code FPA·May 15, 2024
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 8, 2013
ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDO·October 25, 2010
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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015