14 results · 29ms · Sources: EU EUDAMED, US FDA

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CSTS SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015

CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 6, 2015

CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM

FDA Adverse Event
Malfunction ·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015

CAIMAN DISP INSTR ARTICULAT D:12/240MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 16, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL MANUFACTURING CORP·Product code MVK·September 10, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

EDWARDS TRANSCATHETER INTRODUCER SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019

CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

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