26 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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II-Type Intervertebral Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780181538·Integra® Jarit® Probe, Double-Ended, 10"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694089098·Profile 0 Shunt Plate, Wide Groove
Cannula, Suction, acc. Andrew-Pynchon 24.0cm Ø 5mm
FDA UDI
Geister Medizintechnik GmbH·04057034039502·Cannula, Suction, acc. Andrew-Pynchon
24.0cm...
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
FDA 510(k)
FDA Class 2
·Dental
VERSAPULSE MODEL P20 LASER SYSTEM
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·November 15, 2021
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·December 18, 2018
THORACIC PROBE 9734680 NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·November 1, 2019
2520274-2013-03589
FDA Adverse Event
Injury
·SYNTHES USA·Product code MJO·June 20, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·July 27, 2011
SYPCMA+1
FDA Adverse Event
Other
·HILL-ROM CHARLESTON·Product code IKY·September 29, 2008
CARTO 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 14, 2023
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code DIO·December 20, 2017
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis.
FDA Enforcement
Class II
·Terminated·XTANT MEDICAL INC·March 25, 2020
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
FDA Recall
Terminated
·Epigenomics Ag Geneststr. 5 Berlin Germany·Product code PHP·November 2, 2017
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Enforcement
Class III
·Terminated·OraSure Technologies, Inc.·April 25, 2018
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
FDA Enforcement
Class II
·Terminated·Epigenomics Ag·March 28, 2018
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is packaged 25 panels to 1 box.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·December 6, 2017
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
FDA Enforcement
Class II
·Completed·Bard Peripheral Vascular Inc·May 16, 2018