18 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MIRACLELENS
FDA 510(k)
FDA Class 1
·Ophthalmic
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055611·OMNIARCH® EURO 022 UL/5-5 CS HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055221·OMNIARCH® Base Rx 022 UL/5-5 CS-BC HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055621·OMNIARCH® EURO 022 UL/5-5 CS-BC HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055131·OMNIARCH® Base Rx 018 UL/5-5 CS HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055121·OMNIARCH® Base Rx 018 UL/5-5 CS-BC HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055281·OMNIARCH® CETLIN® 022 UL/5-5 CS HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055231·OMNIARCH® Base Rx 022 UL/5-5 CS HK
OMNIARCH®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K77055301·OMNIARCH® BI-DIMENSIONAL® UL/5-5 CS HK
ACID ETCHED LAG SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
FDA 510(k)
FDA Unclassified
·Unknown
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 13, 2007
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·October 3, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON MANUFACTURING, LTD./ HUNTINGTON·Product code HQL·December 19, 2013
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015