27 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SleepRight Snore Aid
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187554·Integra® Jarit® Hibbs Chisel, 9-3/4", Curved, 1/2"
R1 shock-proof black, 1-tube, Velcro cuff obese size
FDA UDI
Rudolf Riester GmbH·04045396159853·Aneroid sphygmomanometers for non invasive meas...
Stainless Steel Goldtone Archwire
FDA UDI
Ortho Arch Company Inc·D9092501221·.017 x .022 STAINLESS STEEL ARCHES RIGHT FORM G...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036037468·
Slap Hammer
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076665·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197162678·Micro Hook
45°, s...
STILLE Retractors
FDA UDI
Stille AB·07332339211936·SKIN HOOK JOSEPH STILLE double hook 2 mm 16 cm ...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250122200·ceraMotion® Zr Incisal Modifier opal white, 20 ...
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
FDA 510(k)
FDA Class 1
·General Hospital
TOMTEC-ARENA TTA2
FDA 510(k)
FDA Class 2
·Radiology
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 14, 2014
UNKNOWN DEPUY 5.0MM SCREW
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code HWC·September 15, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
VISIGLIDE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code OCY·October 15, 2025
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·March 8, 2024
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020