15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IS4000 8mm Harmonic ACE Curved Shears
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAXIM® VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225826·
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205758·
Dropper Urine Chemistry Control Level 1 Set 3x25mL
FDA UDI
QUANTIMETRIX CORPORATION·00896863002202·The Dropper Urine Chemistry Control is intended...
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
FDA 510(k)
FDA Class 2
·Ophthalmic
UNIVERSAL XACTTRACE
FDA 510(k)
FDA Class 2
·Anesthesiology
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
AMISTEM H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025
TM MONOBLOCK TIBIA
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·May 29, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 28, 2011
PERF CON TIB BRG LRG 22X60
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
NON-POROUS PERF TIB TRAY-LGE
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
PERF ANAT TIBIAL STEM 120X14X5
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014