139 results
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49ms
·
Sources: EU EUDAMED, US FDA
PERIFIX®
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code OGE·August 9, 2024
PERIFIX®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code OGE·January 16, 2025
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·July 15, 2022
INTROCAN® SAFETY
FDA Adverse Event
Injury
·B. BRAUN MELSUNGEN AG·Product code DQR·September 29, 2015
Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
PERIFIX SOFT TIP
FDA Adverse Event
Injury
·B. BRAUN MELSUNGEN AG·Product code DQR·July 1, 2016
POWERWIRE RADIOFREQUENCY GUIDEWIRE
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code PDU·January 7, 2021
PERIFIX®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code OGE·February 14, 2025
Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code GTY·May 25, 2022
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·July 26, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·July 10, 2012
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·July 20, 2012
3T Medical Systems Inc.
FDA registration
3T Medical Systems Inc.·3 products·🇺🇸 United States
INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KGC·April 26, 2022
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
CT MEDICAL, INC.·Product code INI·March 5, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
CT MEDICAL, INC.·Product code INI·March 10, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
CT MEDICAL, INC.·Product code INI·March 4, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
CT MEDICAL, INC.·Product code INI·March 10, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
CT MEDICAL, INC.·Product code INI·April 17, 2013