16 results · 29ms · Sources: EU EUDAMED, US FDA

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CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM

FDA 510(k)
FDA Class 2 ·General Hospital

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978959276·DISTRACTOR 9092414 OBL HOUSING 14MM 4DEG

LEONE SPA

FDA UDI
LEONE SPA·08033707065869·EXTRAORAL ELASTICS 3/16" 14 oz

LEONE SPA

FDA UDI
LEONE SPA·08033707065883·EXTRAORAL ELASTICS 5/16" 14 oz

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690198697·AK3 Ultra Insert Trial Size 4, 14mm

PRIME ECG SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE

FDA 510(k)
FDA Class 2 ·General Hospital

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

MARYLAND BIPOLAR FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013

ALARIS PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORP·Product code FPA·September 5, 2014

LYOPLANT ONLAY 2.5X2.5CM

FDA Adverse Event
Injury ·AESCULAP AG·Product code GXQ·March 11, 2020

LYOPLANT ONLAY 2.5X2.5CM

FDA Adverse Event
Injury ·AESCULAP AG·Product code GXQ·February 25, 2020

ANGIODYNAMICS / SMART PORT

FDA Adverse Event
Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 2017

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

FDA Enforcement
Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

FDA Recall
Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

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