28 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
FDA 510(k)
FDA Class 1
·General Hospital
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704629678·Rusch Polaris FO Blade, Mac 1
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704711793·Rusch Polaris FO Blade, Mac 1
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120496·Guidewire 1.1x150mm Sgl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120472·Guidewire 1.1x150mm Dbl Trocar
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100110001·IN-OVATION® C TGO 020X028 U5-5/L3-3 CS-BC HK
OralKleen
FDA UDI
Oralkleen, LLC·00850030081056·Oral Hygiene Kit
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 20, 2024
ATRIUM CENTRILFX MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES (USA) LCP MODULAR FOOT PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Widex
FDA UDI
Widex A/S·05706069558319·Widex UNIQUE U-XP (Dark brown ) 110, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069558302·Widex UNIQUE U-XP (Clay brown ) 110, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069886856·WIDEX MOMENT M-XP (Dark brown ) 110, Telecoil
Widex
FDA UDI
Widex A/S·05706069886832·WIDEX MOMENT M-XP (Light beige ) 110, Telecoil
Widex
FDA UDI
Widex A/S·05706069558296·Widex UNIQUE U-XP (Light beige ) 110, Telecoil,...
Widex
FDA UDI
Widex A/S·05706069886849·WIDEX MOMENT M-XP (Clay brown ) 110, Telecoil
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
FDA Enforcement
Class II
·Terminated·SpineFrontier, Inc.·November 20, 2013
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·January 17, 2017
HIRES 90 K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·May 31, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011