15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAFE CLINIT. D957P-70-100X1
FDA UDI
Radiometer Medical ApS·05700699428929·D957P-70-100x1 safeCLINITUBES Blood Sampler Mul...
Powder-free Clear Vinyl Patient Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Cristaline Aligners Z FLX
FDA 510(k)
FDA Class 2
·Dental
ABL90 FLEX PLUS ANALYZER
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·October 18, 2024
SAFECLINITUBES
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS.·Product code GIO·April 20, 2012
XTRA AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code CAC·December 20, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 5, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 17, 2014
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
FDA Enforcement
Class II
·Terminated·Radiometer Medical ApS·June 10, 2020
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
FDA Recall
Terminated
·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code GIO·March 17, 2020
SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis.
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·June 22, 2006
SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787.
FDA Recall
Terminated
·Radiometer America Inc·Product code GIO·June 29, 2006