14 results · 21ms · Sources: EU EUDAMED, US FDA

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COMPREHENSIVE HUMERAL FRACTURE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GRIP LOCK ANCHOR, MODEL 411374

FDA 510(k)
FDA Class 2 ·Neurology

GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION

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

BD SYRINGE 3ML LL 200 S/C

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 21, 2025

GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

GEM SPLT SET Y-EXT BCKCHK 282CM

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014

GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 27, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2011

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·April 3, 2008

LOGIC TIBIA PS MOD INSRT SZ 5 9MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·September 10, 2024

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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014