15 results
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21ms
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Sources: EU EUDAMED, US FDA
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