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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM

FDA 510(k)
FDA Class 1 ·Anesthesiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033897·Baltic Denture System BDLoad BDLoad ↓ Mn6 PLSEu...

SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW

FDA 510(k)
FDA Class 2 ·Radiology

ENDIUS BIPOLAR SHEATH

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

ACCU-CHEK FLEXLINK

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007

ACCU-CHEK FLEXLINK

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007

ACCU-CHEK FLEXLINK

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 20, 2007

FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015

ACCU-CHEK FLEXLINK

FDA Adverse Event
Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·March 29, 2007

FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
ANI [ A&I ] GROUP TAIWAN·Product code IOR·April 3, 2013

CROSSER RECANALIZATION CATHETER

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·March 18, 2011

PUMP MMT-522NAS PRDGM INS V2.2 SK EN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·April 24, 2008

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013