19 results · 29ms · 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.

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760

FDA 510(k)
FDA Class 2 ·Immunology

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...

NA

FDA UDI
STRYKER CORPORATION·04546540893598·8.0mm Caspar Blade

MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

FDA 510(k)
FDA Class 2 ·Cardiovascular

MULTISTIM

FDA 510(k)
FDA Class 2 ·Anesthesiology

TACTICATH

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC.·Product code OAE·January 31, 2018

SEE H10

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·April 2, 2013

ETRAK PLUS

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·March 16, 2011

HARMONY SLIDER

FDA Adverse Event
Malfunction ·ABBOTT SPINE, INC.·Product code GAD·April 18, 2008

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·September 16, 2025

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 TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016