25 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VariSeed (v10)
FDA 510(k)
FDA Class 2
·Radiology
POYA 3.5mm Lateral Proximal Tibia Plate, 18 Hole, Right
FDA UDI
Bonebridge AG·07640187462043·
NA
FDA UDI
Medos International Sàrl·10886705011124·ACORN REAMER, STERILE 20 - 130mm (Plus or Minus...
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380083426·3.2mm Guide Wire 400mm
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277103406·Arthoscopy Menicus Repair Rasp Set with Case
TP Original Wire
FDA UDI
TP ORTHODONTICS INC·00192029028865·Standard Round
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102886·BECHERT NUCLEUS ROTATOR 7MM
G185
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120086·G185 Incubator for assisted reproduction
G185
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120093·Incubator for Assisted reproduction
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702777789·ELVAREX 2/KNEE HIGH/CLOSED TOE-ELEPHANTIASIS-VE...
ANESTHESIA 17GAX18CM DURASAFE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code CAZ·August 20, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 1, 2022
LAFACI
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LP(A) CALIBRATORS, AND LP(A) CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·March 22, 2021
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·November 6, 2014
SIGMA SPECTRUM INFUSION PUMP
FDA Adverse Event
Injury
·SIGMA LLC·Product code FRN·August 31, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 18, 2013
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code FMZ·June 30, 2021
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·August 25, 2021