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

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C. NET 2100

FDA 510(k)
FDA Class 2 ·Cardiovascular

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890103960·Zirlux UCLA Plastic Abut Eng

Vivid Elegance Algisub FS

FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0103960·50ml x 2

Ovation Tribute Hip Stem

FDA UDI
Ortho Development Corporation·00822409032983·STD Size 10.5 Stem Plasma Spray

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 12, 2025

APNOESCREEN PRO, ALPHA SCREEN PRO

FDA 510(k)
FDA Class 2 ·Anesthesiology

MULTI CARE THERAPEUTIC VIBRATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ACIST

FDA Adverse Event
Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 11, 2007

ASR UNI FEMORAL IMPL SIZE 51

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 19, 2013

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 8, 2011

ACIST

FDA Adverse Event
Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

ACIST

FDA Adverse Event
Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 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

Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019