13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ECHOCOM, IMAGECOM, DOKUCOM
FDA 510(k)
FDA Class 2
·Cardiovascular
TruForm
FDA UDI
Rmo, Inc.·00885797099716·MD MLR BDS R/L SE ASIA ASST100
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·ECWG0015921·CC/ Gingiva G2 dark pink
Creation Willi Geller
FDA UDI
KLEMA Dentalprodukte GmbH·09010782022979·CC/ Gingiva G2 dark pink
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001592·artVeneer life lower anteriors, UIM, BL2
UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
GENERIC BLOOD GLUCOSE TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PUMP IN STYLE BREAST PUMP
FDA Adverse Event
Injury
·MEDELA, INC.·Product code HGX·March 11, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·February 25, 2011
ANTI-D (MONOCLONAL BLEND) SERIES4
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·February 25, 2008
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024