14 results · 28ms · Sources: EU EUDAMED, US FDA

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CONPHAR ARM SLINGS

FDA 510(k)
FDA Class 1 ·Physical Medicine

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113936·GIANNETTI "BIG SPURT" CANNULA 21GA

VIPERSPHERE PTA BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SEARLE PHO/SONIC ALPHA 2000

FDA 510(k)
FDA Class 2 ·Radiology

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 15, 2024

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 28, 2025

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 9, 2014

P.F.C.* PRESS-FIT ROD WRENCH

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 19, 2016

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 28, 2015

COBAS 6000 C (501) MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 14, 2025

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

FDA Enforcement
Class II ·Terminated·BioHorizons Implant Systems Inc·December 26, 2012

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024