16 results · 27ms · 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.

EBI DYNAFIX COMPRESSION BONE SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307061·Diamond, flame, medium grit

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0300060·Egg Handle, 1.75" Fixed Qtr Sq Cann Imp Crimson

THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER

FDA 510(k)
FDA Class 2 ·Cardiovascular

DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

AISYS

FDA Adverse Event
Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

VERTE-STACK K030736, K041197

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

FDA Enforcement
Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

YALE NH TT VISION SYS GBS

FDA Adverse Event
Other ·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 22, 2014

PELVISOFT ACELLULAR COLLAGEN BIOMESH

FDA Adverse Event
Injury ·C.R. BARD, INC.·Product code FTM·March 18, 2011

FLEXIMA ALL PURPOSE DRAINAGE CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FFA·April 15, 2008

Isulin Pump. Model IR1000

FDA Recall
Terminated ·Animas Corporation·Product code LZG·October 31, 2005

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