13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFIX ANTERIOR LUMBAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027520·
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
FDA 510(k)
FDA Class 1
·General Hospital
MICROMLC
FDA 510(k)
FDA Class 2
·Radiology
V.A.C.ULTA THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 23, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
MPACT HC PE FIXED FLAT LINER 36
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2014
MITEK FASTIN NON ABSORBABLE ANCHOR IMPLANT
FDA Adverse Event
Injury
·DEPUY MITEK·Product code JDR·August 27, 2015
SI BRITE TIP
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DYB·May 29, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 17, 2011
MONARC SLING
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code FTL·August 21, 2008
UNK - IMPLANTS
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·October 21, 2019
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015