19 results · 22ms · Sources: EU EUDAMED, US FDA

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SIGNA 3.0T MAGNETIC RESONANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Safco polycarbonate crowns

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310223973·Safco polycarbonate crowns #69 5/box

ZYGOMATIC IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·September 11, 2024

M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

URISYS 2400 URINE TEST STRIP

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 27, 2025

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·November 9, 2010

TRANSEND GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

LAMITRODE S8

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 22, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·February 16, 2011

EMBRACE PUMP

FDA Adverse Event
Malfunction ·Product code LZH·March 26, 2008

TRANSEND GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

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