16 results · 30ms · 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.

NATURALASE LP ND:YAG LASER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

CYNOSURE ACCLAIM DERMATOLOGY LASER

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

PARADIGM 1.5ML RESERVOIR, MODEL 326

FDA 510(k)
FDA Class 2 ·General Hospital

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

RATCHET T-HANDLE 6MM QC

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HXX·April 2, 2013

HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·March 25, 2011

PINN MAR NEUT 36IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 18, 2008

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

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