14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CLEARFIL TRI-S BOND PLUS
FDA 510(k)
FDA Class 2
·Dental
MAXCUT CARBIDE BUR (100/pk) FGSS 4
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119801·MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size:...
Relief Pak 4 pack heating Unit stationary
FDA UDI
KARIS Co.,Ltd·08809520550536·It is a device intended for medical purposes th...
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTRIMAG RETURN CANNULA KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
MCGRATH
FDA Adverse Event
Injury
·AIRCRAFT MEDICAL LIMITED·Product code CAL·November 13, 2018
POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG (TPS) STYLET:
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·May 7, 2013
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021