29 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814701·GENUMEDI SILVER SIZE VII
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009021·BELLA STRONG 15-20 MM HG ARMSLEEVE DOT BAND SIZ...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801033940·Thin 7mm Paddle Distractor
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
FRESENIUS OPTIFLUX 200NR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CM DRIVE IMPLANT 4.3X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 8, 2019
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
CM DRIVE ACQUA IMPLANT 4.3X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·January 22, 2019
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 30, 2013
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 27, 2014
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL, INC.·Product code MND·May 23, 2011
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021
KIT FLU VERITOR SYSTEM 30 TEST JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025