16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REVERE CROSSTOP
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST Anti-Embolism
FDA UDI
BSN MEDICAL, INC.·00035664114794·ANTI-EMB STOCKINGS THIGH HIGH CLOSED TOE SMALL ...
Bernafon
FDA UDI
Bernafon AG·05711584004616·CT7 M, VC PS SF BE CANTEO 7
MAXCUT CARBIDE BUR (10/pk) RA 4
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114791·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964105401·The ENDO CARRY-ON Procedure Kit contains all of...
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
RENEW LAPAROSCOPIC ENDOCUT SCISSORS TIP
FDA Adverse Event
Malfunction
·MICROLINE SURGICAL, INC·Product code GEI·May 9, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
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