4,923 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RapidWeld Blade Module Kit
FDA UDI
GENESIS BPS LLC·10866305000254·The Blade Module consists of a stainless steel ...
RapidWeld Blade Module Kit
FDA UDI
GENESIS BPS LLC·10866305000230·The Blade Module consists of a stainless steel ...
RapidWeld Blade Module Kit
FDA UDI
GENESIS BPS LLC·10866305000247·The Blade Module consists of a stainless steel ...
Genesis RapidWeld STW Sterile Tube Welder
FDA UDI
GENESIS BPS LLC·00866305000202·The Genesis Rapid Weld STW is a medical device ...
Genesis RapidWeld II STW Sterile Tube Welder
FDA UDI
GENESIS BPS LLC·00866305000264·The Genesis RapidWeld II STW, model GRW-430-02,...
SOLARA
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·December 2, 2021
SOLARA
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·June 2, 2022
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiant
FDA Recall
Open, Classified
·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/CE Plug, ASSY-LAU, Omnibed Czech S-PH w/Nist O2 w/Reus Probe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Czech S-PH w/Reusable Probe CE Power Cord, Finished good - Make, Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port hole/Ce Plug, ASSY-LAU, Omnibed Indonesian S-GR W/Reuseable Probe CE Plug, Finished good - Make, ASSY-LAU, Omnibed ENG S-Gr w/REUProbe CE Power Cord, Finished good - Make, ASSY-LAU, Omnibed Portuguese S-PH w/NIST O2w/Reusable Probe CE Power Cord, Finished good - Make. Incubator, Neonatal, Warmer, Infant radiant
FDA Enforcement
Class II
·Ongoing·DATEX--OHMEDA, INC.·July 12, 2023
Antisera, All Fluorescent, Leptospira Spp.
FDA classification
FDA Class 2
·Antisera, All Fluorescent, Leptospira Spp.
GLW, Inc.
FDA registration
GLW, Inc.·22 products·🇺🇸 United States
DRW MEDICAL
FDA registration
DRW MEDICAL·6 products·🇺🇸 United States
GRD BIOMECHANICS
FDA registration
GRD BIOMECHANICS·1 product·🇺🇸 United States
CRW STEREOTACTIC SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CRW-1 SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MD Orthopaedics
FDA UDI
MD ORTHOPAEDICS, INC.·00810060884515·AFO SIZE 1 RIGHT GRAY
MD Orthopaedics
FDA UDI
MD ORTHOPAEDICS, INC.·00810060883853·AFO SIZE 0 RIGHT GRAY
HEAD RING DRIVE (BRW & CRW)
FDA Adverse Event
Malfunction
·INTEGRA BURLINGTON, MA, INC.·Product code HAW·December 19, 2012
HEAD RING WRENCH (BRW & CRW)
FDA Adverse Event
Malfunction
·INTEGRA BURLINGTON, MA, INC.·Product code HAW·January 8, 2016
Ponseti® Lite
FDA UDI
MD ORTHOPAEDICS, INC.·00810060880432·Lite Size 1 Right Gray