16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITEK 2 GRAM POSITIVE GATIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526785397·M4S COMFORT COMPACT BLACK RIGHT L
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032314·Baltic Denture System BDLoad Lm6 PLSEbil/2DF B1...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120323141·Diamond, torpedo, COOL DIAMANT, fine grit, red ...
AXIS-SHIELD DIAGNOSTICS, LTD.
FDA registration
AXIS-SHIELD DIAGNOSTICS, LTD.·14 products·🇬🇧 United Kingdom
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR
FDA 510(k)
FDA Class 1
·General Hospital
DYONICS ELECTROBLADE RESECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OASYS BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWP·November 30, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 12, 2026
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·March 23, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·April 21, 2008
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024