21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED
M2A ACETABULAR SYSTEM
FDA 510(k)
FDA Class 3
·Orthopedic
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040006030·Sterilization Tubing Cont Ind
6.5 Cancellous Bone Shaft Screw, hex, St.Steel, L 110/32 mm
FDA UDI
mahe medical gmbh·EMAH00100111100·6.5 Cancellous Bone Shaft Screw, hex,
St.Ste...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659173941·6.5 Cancellous Bone Shaft Screw, hex, _x000D_...
CRYSTAL-EEG MODEL 15
FDA 510(k)
FDA Class 2
·Neurology
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
FDA 510(k)
FDA Class 1
·General Hospital
PROTECTOR P21
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·June 1, 2021
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 29, 2025
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·February 1, 2016
S-ROM*LINR M SERIES,0 DEG,28MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·March 19, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 8, 2011
AFFINITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008
VALIANT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 17, 2014
TALENT AAA
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 17, 2014
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·January 20, 2026
Kroger Sterile Preserved Saline Solution 12oz, Product SKU#011110-385956. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
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