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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MODIFICATION TO CLEARFIL PHOTO BOND

FDA 510(k)
FDA Class 2 ·Dental

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

NC TREK

FDA UDI
ABBOTT VASCULAR INC.·08717648150982·NC TREK Coronary Dilatation Catheter 1.50 mm x ...

NC TREK

FDA UDI
ABBOTT VASCULAR INC.·08717648151019·NC TREK Coronary Dilatation Catheter 1.50 mm x ...

NC TREK

FDA UDI
ABBOTT VASCULAR INC.·08717648150999·NC TREK Coronary Dilatation Catheter 1.50 mm x ...

NC TREK

FDA UDI
ABBOTT VASCULAR INC.·08717648151002·NC TREK Coronary Dilatation Catheter 1.50 mm x ...

NC TREK

FDA UDI
ABBOTT VASCULAR INC.·08717648150975·NC TREK Coronary Dilatation Catheter 1.50 mm x ...

I IMAGE

FDA UDI
FGX INTERNATIONAL INC.·00193033399668·

I IMAGE

FDA UDI
FGX INTERNATIONAL INC.·00193033399675·

STRATO X

FDA 510(k)
FDA Class 2 ·Dental

FIRST SPEP

FDA 510(k)
FDA Class 2 ·Dental

Solidity Vertebral Body Replacement

FDA UDI
Ulrich Medical Usa, Inc.·00814386022309·Center piece, magenta, Ø 13mm, height 24-32mm, ...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

JIG, PARS

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·June 20, 2025

DISPOSABLE FALOPE-RING BAND APPLICATION KIT

FDA Adverse Event
Injury ·GYRUS MEDICAL INC.·Product code KNH·March 15, 2013

COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 9, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 13, 2008

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·September 19, 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