13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Benesta Tissue Removal Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103401·KIMURA PLATINUM SPATULA
TP Original Wire
FDA UDI
TP ORTHODONTICS INC·00192029028940·Standard Round
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376364803·IdentiTi ALIF SA, Awl, Straight
BD CAREFLOW CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
RetCam Envision
FDA 510(k)
FDA Class 2
·Ophthalmic
T:SLIM G4 SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OYC·October 13, 2016
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 6, 2014
SENSAR
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·September 2, 2011
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·November 27, 2013
MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 29, 2024
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013