17 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MICROSURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·Neurology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156012·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 230mm
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
FDA 510(k)
FDA Class 2
·Orthopedic
SURGIQUEST AIRSEAL IFS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IOLMASTER 700
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·January 19, 2024
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·September 22, 2017
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·October 24, 2018
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·September 22, 2017
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·April 3, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·January 18, 2013
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code HQL·December 8, 2010
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·May 5, 2017
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·July 12, 2017
IOLMaster 700
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·February 24, 2021
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
FDA Recall
Terminated
·Carl Zeiss Meditec AG Carl-Zeiss-Promenade 10 Jena Germany·Product code HJO·June 25, 2018
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·July 3, 2016
IOLMASTER 700
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·July 3, 2016