27 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TROPHON CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113912·VISCO INJECTION CANNULA 23GA
PARALLEL WIRE EXTRACTION PLIERS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051553·PARALLEL WIRE EXTRACTION PLIERS WITH TUNGSTEN C...
HUDSON ET TUBE, HVT, 6.0
FDA Adverse Event
Injury
·TELEFLEX MEDICAL·Product code BTR·June 20, 2018
N LP(A) STANDARD SY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIPOLAR TRIGGER-FLEX PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 15, 2023
LINER: MPACT FLAT PE HC LINER Ø36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 22, 2021
4103-126 WITH LARGER PIN SIZE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·April 26, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 20, 2015
HITACHI 902 ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 9, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 19, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON·Product code FTL·May 25, 2011
EVERSENSE SENSOR
FDA Adverse Event
Malfunction
·SENSEONICS INC.·Product code QHJ·July 13, 2025
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code NBC·July 25, 2012
Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·September 12, 2012
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024
dS Breast 16ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024