20 results · 26ms · Sources: EU EUDAMED, US FDA

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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