17 results
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25ms
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Sources: EU EUDAMED, US FDA
JOHNLOZ ENDOSCOPY HANDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105281·KIT, OCHO - BASIC - RED/GREY
SMR REVERSE HUMERAL BODY SHORT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·June 29, 2022
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197491648·Genuine Case, only
537x25...
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SMR REVERSE HUMERAL BODY SHORT
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·April 1, 2019
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 8, 2014
CPR-2
FDA Adverse Event
Malfunction
·MERCURY MEDICAL·Product code BTM·October 12, 2012
PARADYM
FDA Adverse Event
Injury
·SORIN BIOMEDICA C.R.M., S.R.L.·Product code MRM·August 10, 2010
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code FQH·January 24, 2019
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021