11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PROXIMATE ILS CIRCULAR STAPLES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OraCure
FDA 510(k)
FDA Unclassified
·Unknown
PROXIMATE ILS CIRCULAR STAPLERS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 27, 2014
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC·Product code OTO·February 28, 2013
ASR ACETABULAR IMPLANT 44
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
AXIUM PRIME BRPL HLX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·September 3, 2020
Transvaginal Pack, part number CMP1767
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024