21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
FDA 510(k)
FDA Class 2
·Radiology
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608396·ALLEN, STERIS-AMSCO 5.25"DELUXE GEL
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·August 18, 2022
Welch Allyn, Inc.
FDA UDI
WELCH ALLYN, INC.·00732094032789·LT LG CLR DPLY IN W CHGCRA USB PLUG I
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472260·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472239·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472307·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472291·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472277·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472246·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472284·
FIX-L PEEK PLIF and T-PLIF System
FDA UDI
Jeil Medical Corporation·08800089472253·
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·August 18, 2022
MDI SCL-70 TEST
FDA 510(k)
FDA Class 2
·Immunology
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE DIABETES CARE AG·Product code LZG·April 26, 2013
EGIA 45 ARTICULATING VAS/MED SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GDW·July 9, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 8, 2011
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·August 18, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024