20 results
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26ms
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Sources: EU EUDAMED, US FDA
TRIPORE, MODELS HA, BP90, BP15
FDA 510(k)
FDA Class 2
·Orthopedic
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696301·Nylon Ball Abutment Retentive Cap Extra Soft - ...
Varnish America 0.25ml Box / 200 White Mint
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·10302730701323·0.25ml Box / 200 count
DENTAL ATTACHMENTS
FDA UDI
RHEIN 83 SRL·08059224195193·DISPOSABLE device in plastic material to be emb...
NeVasc .070 Aspiration Catheter, 132 cm
FDA UDI
Vesalio·00851279008989·The NeVasc Aspiration System consists of 1) NeV...
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
FDA 510(k)
FDA Class 2
·Dental
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
FDA 510(k)
FDA Class 2
·Immunology
pVasc Aspiration Catheter 70, 132 cm
FDA UDI
Vesalio·00851279008934·The pVasc® Aspiration Catheter System consists ...
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
SERIES TWENTY THOUSAND LEGACY
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQE·July 3, 2008
POSTERIOR CHAMBER LENS
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 22, 2011
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 5, 2016
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 3, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·April 16, 2018
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021