12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACRO HCG Pregnancy Rapid Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
FDA 510(k)
FDA Class 2
·General Hospital
RMS SUBCUTANEOUS NEEDLE SET
FDA 510(k)
FDA Class 2
·General Hospital
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Injury
·ZOLL CIRCULATION·Product code NCX·May 31, 2022
WIRE, GUIDE, CATHETER
FDA Adverse Event
Injury
·ZOLL CIRCULATION, INC·Product code DQX·July 30, 2022
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·July 22, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·September 19, 2008
VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 23, 2017
EASYPUMP
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code MEB·June 20, 2023
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022