17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITA SUPRINITY(R)
FDA 510(k)
FDA Class 2
·Dental
RC Cem. Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600306122·
NexxZr™ T / D-100-16-NT-B200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112804·
Forestanit®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21320701·Forestanit wire round spring-hard laboratory co...
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981192662·Interbody, 11mm x 32mm x 7mm, 0 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981200657·Interbody, 11mm x 32mm x 7mm, 0 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981207779·Trial, 11mm x 32mm x 7mm, 0 deg
Portex
FDA UDI
ICU MEDICAL, INC.·15019315020322·
ELCACAM
FDA 510(k)
FDA Class 1
·Dental
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 16, 2011
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 11, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019