19 results · 26ms · Sources: EU EUDAMED, US FDA

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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