15 results · 21ms · Sources: EU EUDAMED, US FDA

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FDA Adverse Event
Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

AESCULAP STERILCONTAINER SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

PROWLER

FDA UDI
Medos International Sàrl·10886704028680·PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694060301·10mm Angled Locking Screw ID Tag

MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SMARTLENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

OT VERIO METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 17, 2013

EON MINI RECHARGEABLE IPG

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 22, 2011

WALLFLEX ENTERAL COLONIC STENT

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code MQR·June 18, 2008

20 G X 1.16 IN. (1.1 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 25, 2017

EMBOTRAP II 5X33 REVASC. DEV.

FDA Adverse Event
Malfunction ·NEURAVI LTD.·Product code NRY·October 29, 2019

PROWLER PLUS 20CM TIP, 150 CM

FDA Adverse Event
Malfunction ·CODMAN AND SHURTLEFF, INC·Product code KRA·October 29, 2019

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

FDA 510(k)
FDA Class 2 ·Neurology

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015