22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mapping Suction Probe
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM
Origin Stem Size 14 Template
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055936·
MODEL 2121-64; TMJ SURFACE COIL
FDA 510(k)
FDA Class 2
·Radiology
MR VESSELLQ XPRESS
FDA 510(k)
FDA Class 2
·Radiology
'RAPIDONE'-METHADONE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·August 15, 2011
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 29, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 11, 2023
RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 12, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 15, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 5, 2023
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·April 22, 2025
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·July 10, 2019