20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPRI Corpectomy Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694016056·Spectrum Distraction Tool, Horizontal Adjustment
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Enforcement
Class II
·Completed·Teleflex Medical Europe Ltd·August 25, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Recall
Open, Classified
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055001·MTM® NO TRACE (TM) 018 UL/4-4
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055011·IN-OVATION® L 018 UPPER 6-6
IN-OVATION® L
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055101·IN-OVATION® L 018 UL/7-7
BLOOD PRESSURE METER, MODEL CH-609
FDA 510(k)
FDA Class 2
·Cardiovascular
BONALIVE GRANULES AND BONALIVE PLATES
FDA 510(k)
FDA Class 2
·Dental
BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 30, 2021
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
25 GA POSTERIOR WIDE-FIELD ELITE PACK
FDA Adverse Event
Malfunction
·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 14, 2013
SCORPIO TS MOD. TIB. TRAY
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 13, 2011
D-FLEX TRIANGULAR RETRACTOR 80MM 5MM
FDA Adverse Event
Injury
·CAREFUSION·Product code GCJ·August 20, 2014
STELLARIS POWER SUPPLY II
FDA Adverse Event
Malfunction
·BAUSCH + LOMB·Product code HQC·August 1, 2023
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023