30 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918125107·Micro-embossed Plastic_Oval Aperture Drape_Mini...
PARIETEX COMPOSITE (PCO) MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
2.4MM VA LOCKING SCREW STARDRIVE 22MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·June 25, 2013
APOLLO GENERATOR
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code GWG·June 11, 2015
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HRS·July 15, 2013
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 19, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011
2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·June 21, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·December 24, 2015
SOLITAIRE FR
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·May 15, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
2.4MM TI LOCKING SCR SLF-TPN WITH STARDRIVE RECESS 18MM
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HWC·June 21, 2017
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code NJE·May 12, 2023
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA Enforcement
Class II
·Terminated·BioHorizons Implant Systems Inc·December 26, 2012
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 6, 2024