13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
FDA 510(k)
FDA Class 2
·Neurology
Better Faster Cheaper (BFC) Syringes
FDA UDI
PRACTICON, INC.·00723896010662·offers tremendous advantages over the standard ...
LEONE SPA
FDA UDI
LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown
EndoPilot Motor
FDA UDI
Schlumbohm GmbH & Co. KG·04260482990084·EndoPilot Motor with ISO-E standard; LED-indica...
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101120·Distractor, Smooth Paddle, Lordotic, 12mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312L0101120·Distractor, Smooth Paddle, 12mm
BIPOLAR COAGULATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
FDA 510(k)
FDA Class 1
·Dental
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
PULSE GEN MODEL 101
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·September 15, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
SINGLE-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 22, 2011
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024