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

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40 L HIGH FLOW INSUFFLATOR F108

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Hegar Dilator

FDA UDI
MEDGYN PRODUCTS, INC.·M803030837·Hegar Dilator 13-14mm

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

FDA UDI
TENON MEDICAL, INC.·B74240308370·10mm Funnel Flange

PUMA DENTAL CHAIR AND UNIT

FDA 510(k)
FDA Class 1 ·Dental

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TERUMO TCM II COOLING AND HEATING SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWC·March 28, 2013

TERUMO CENTRIFUGAL SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·March 4, 2011

MULTI-LINK OTW VISION CORONARY STENT SYSTEM

FDA Adverse Event
Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 17, 2008

ENDURANT II STENT GRAFT

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·October 21, 2020

ENDURANT II STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·October 21, 2020

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018