17 results · 20ms · Sources: EU EUDAMED, US FDA

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BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673174·LEVAMED STABILI-TRI ANK BLU R I

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040056455·Zirlux Multi Anterior B1,98.5X20

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I

G-aenial™

FDA UDI
Gc America Inc.·D0470123511·G-aenial Univ. Injectable Unitip A3.5

ACS HI-TORQUE GUIDE WIRE

FDA Adverse Event
Injury ·GUIDANT, ADVANCED CARDIOVASCULAR SYSTEMS·Product code DQX·February 13, 2002

FLUOROTEX II SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HTJ·February 3, 2025

AGILTRAC .035 PERIPHERAL DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·August 25, 2008

DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HTJ·February 6, 2025

T-SLING

FDA Adverse Event
Injury ·HERNIAMESH S.R.L.·Product code PAH·March 7, 2013

SAFE-T-PRO PLUS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 9, 2011

CHARITE ARTIFICIAL DISC, SIZE UNK

FDA Adverse Event
Injury ·DEPUY SPINE, INC.·Product code MJO·February 12, 2008

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·December 7, 2016

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