14 results · 24ms · Sources: EU EUDAMED, US FDA

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CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ISOLA

FDA UDI
DEPUY SPINE, LLC·10705034004440·ISOLA SPINE SYSTEM CLOSED BODY-NO ROD 6.35mm

PharmGuard

FDA UDI
ICU MEDICAL, INC.·15019517151107·

CHARNLEY OGEE CUP 22.225/40MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 13, 2004

MICROPOBE SERIES OF LASERS AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

FDA 510(k)
FDA Class 2 ·Ophthalmic

RADIESSE DERMAL FILLER

FDA Adverse Event
Other ·MERZ AESTHETICS, INC.·Product code LMH·February 28, 2012

PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2013

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 15, 2014

SYNFIX LR 26MM DEPTH/32MM

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code MAX·April 16, 2008

Spirit One A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

Spirit One A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024