25 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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G-2 V5
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Reusable Skin Temperature Probe
FDA UDI
MEASUREMENT SPECIALTIES, INC.·H2974270·Reusable Temperature Probe – Skin (Pediatric)
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609652·MAQUET 2" STANDARD
MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
FDA 510(k)
FDA Class 2
·General Hospital
COMFORT STIM
FDA 510(k)
FDA Class 2
·Neurology
CHRONOS(TM) BETA-TCP STRIP 100MM X 25MM X 3MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code MQV·April 26, 2013
SOFTPORT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB SURGICAL·Product code MSS·August 29, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·April 14, 2011
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.
FDA Enforcement
Class II
·Terminated·Stryker Communications·March 7, 2018
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
DAVINCI SI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2020
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·August 22, 2022
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
FDA Adverse Event
Injury
·COOK INC·Product code FOZ·August 22, 2022
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 3, 2018
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·July 3, 2018
TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·June 25, 2018
Catheter, intravascular, therapeutic, short-term less than 30 days
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·November 10, 2022
LEGION HK HINGE KNEE SYSTEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025