23 results
·
25ms
·
Sources: EU EUDAMED, US FDA
IBA PROTON THERAPY SYSTEM- PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
PMMA disc
FDA UDI
Dentsply International Inc.·D00180824160·
GOLDEN-RULE SCALING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CONFOSCAN 2 CONFOCAL MICROSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·April 29, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·May 9, 2011
XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code NKB·July 18, 2008
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
81-082416 OEM FOLEY CATH 16FR 400 MALE
FDA Adverse Event
Malfunction
·DEROYAL·Product code KOD·December 19, 2000
81-082416 OEM FOLEY CATH.16FR 400 MALE
FDA Adverse Event
Malfunction
·DEROYAL·Product code KOD·December 19, 2000
81-082416 OEM FOLEY CATH.16FR 400 MALE
FDA Adverse Event
Malfunction
·DEROYAL·Product code KOD·December 19, 2000
AVAN TAP CORT SCR SS 4.5X26MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X56MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X60MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X20MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
AVAN TAP CORT SCR SS 4.5X52MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
M2A ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013