21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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