18 results · 18ms · Sources: EU EUDAMED, US FDA

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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