23 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Precept
FDA UDI
Nuvasive, Inc.·00887517345363·PRECEPT Screwdriver, Polyaxial
Vista 1.5mm Frazier Style Surgical Aspirator
FDA UDI
Vista Dental·10818207021486·
N/A
FDA UDI
inomed Medizintechnik GmbH·04250307605736·RM dove tail guide, short
N/A
FDA UDI
inomed Medizintechnik GmbH·EINO8010159·RM dove tail guide, short
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022166·FastTrack Demo Kit, Pediatric, Universal
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377022173·FastTrack Demo Kit, Adult, Universal
INTRA-AORTIC BALLOON CATHETER
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 27, 1998
ELECSYS THYROGLOBULIN CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Fragment Case
FDA UDI
Zimmer, Inc.·00889024068070·
M2A-MAGNUM MOD HD SZ 56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·May 27, 2015
ALL-IN-ONE CCU+LIGHT ROW
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code FCW·July 28, 2020
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