9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TARGET DEVICE 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 2, 2012
ArgenZ HT+ 98x20 A1
FDA UDI
ARGEN CORPORATION, THE·D818122836·Dental porcelain/ceramic restoration kit
BONASIL A+ IMPRESSION MATERIALS
FDA 510(k)
FDA Class 2
·Dental
STEPHENS DISPOSABLE SPECULUM
FDA 510(k)
FDA Class 1
·Ophthalmic
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 21, 2013
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·June 14, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·August 14, 2008
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021