28 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Paparella
FDA UDI
MEDTRONIC XOMED, INC.·00613994146106·VENT TUBE 1082201 5PK PAPA TYPE 1.14
Microgel®
FDA UDI
MEDTRONIC XOMED, INC.·00763000037451·VENT TUBE 1082201 5PK PAPA TYPE 1.14
Harvard PremiumFill A1
FDA UDI
Harvard Dental International GmbH·EHAR70822011·Universal light cure nano-hybrid composite for ...
Microgel
FDA UDI
MEDTRONIC XOMED, INC.·00763000870355·VENT TUBE 1082201 5PK PAPA TYPE 1.14
NaturaLyte
FDA UDI
Fresenius Medical Care Renal Therapies Group, LLC·00840861101672·NaturaLyte Liquid Acid Concentrate for Bicarbon...
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX
FDA Adverse Event
Death
·ATRICURE, INC.·Product code OCL·November 13, 2018
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·May 9, 2011
DASH 4000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES·Product code MHX·July 22, 2008
PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019
PREMICRON GREEN 2/0 (3) 30CM SKR19(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON GREEN 2/0 (3) 75CM HR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·January 20, 2021