19 results
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26ms
·
Sources: EU EUDAMED, US FDA
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
FDA 510(k)
FDA Class 2
·Neurology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496052111·VENERE 70 OPEN TOE, SIZE M, MIELE, GRADUATED CO...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849028·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE EXTRA ...
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
FDA 510(k)
FDA Class 1
·General Hospital
ACUSON CV70 CARDIOVASCULAR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SLEEPEASY
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·April 12, 2012
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 6, 2010
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·November 25, 2009
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
SCREW POSITIONING KNOB
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·February 23, 2023
OPTIFLEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·April 11, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 2, 2014
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 12, 2011
REMSTAR PLUS M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·March 16, 2012
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code BZD·February 24, 2010
REMSTAR PLUS M
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 21, 2010
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·December 1, 2010
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 26, 2011
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025