11 results · 20ms · Sources: EU EUDAMED, US FDA

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K082959

FDA UDI
Unimed Medical Supplies, Inc.·06945664812412·SpO2 interface cable/Philips-Masimo/2.2M/309+12...

Unimed

FDA UDI
Unimed Medical Supplies, Inc.·06936735463947·One-piece ECG Monitor Cable Philips

PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO ISOBAR SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MESH- COMPOSIX KUGEL

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 23, 2013

NEXGEN FLUTED STEMMED TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·May 3, 2011

CALAXO - UNKNOWN

FDA Adverse Event
Other ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·July 25, 2008

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·June 8, 2011

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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