15 results · 28ms · 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.

XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116

FDA 510(k)
FDA Class 2 ·Microbiology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450554906·

RESOLVE SURGICAL O.R. TOWELS

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

HORIZONS INTERNATIONAL POLYPECTOMY SNARES

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

CELL-DYN DILUENT/SHEATH

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

UNK - SCREW

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

UNK - SCREW

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

UNK - SCREW

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code KWA·July 26, 2011

UNK - SCREW

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

PASSPORT 2 MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC·Product code DSI·April 30, 2013

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 17, 2011

Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

FDA Enforcement
Class II ·Terminated·Greatbatch Medical·June 8, 2016

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