13 results · 22ms · 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.

MERETE LOCKING BONE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

exsalt PT7 Contact Layer, 6" x 6"

FDA UDI
Exciton Technologies Inc·07540127000376·The exsalt™ PT7 Contact Layer (PT7) is indicate...

RTE SNAPCONE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

INSPEKTOR PRO

FDA 510(k)
FDA Class 2 ·Dental

COUCH FOR TOTAL BODY RADIATION

FDA 510(k)
FDA Class 2 ·Radiology

COPPERHEAD CERVICAL INTERBODY CAGE

FDA Adverse Event
Injury ·EMINENT SPINE·Product code ODP·January 8, 2016

REAR TIP EXTENDER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025

RTE SNAPCONE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013

GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

FDA Adverse Event
Injury ·COOK, INC.·Product code DTK·May 5, 2011

UNKNOWN DEPUY FEMORAL

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSA·July 30, 2008

STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

FDA Recall
Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

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