11 results
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18ms
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Sources: EU EUDAMED, US FDA
MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
FDA 510(k)
FDA Class 2
·Microbiology
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029046975·UL CEN
SeaSpine Spacer System - Pacifica™
FDA UDI
Seaspine Orthopedics Corporation·10889910058809·Pacifica Trial, 9mm x 24mm x 8mm
SeaSpine Spacer System - Pacifica™
FDA UDI
Seaspine Orthopedics Corporation·10889981058807·Pacifica Trial, 9mm x 24mm x 8mm
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
FDA 510(k)
FDA Unclassified
·Unknown
1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES
FDA 510(k)
FDA Class 2
·Dental
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 29, 2013
PORTEX BLUE LINE UNCUFFED TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD·Product code BSR·December 13, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020