23 results
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21ms
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Sources: EU EUDAMED, US FDA
Globe Introducer (601-01001)
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197441186·Micro Ball Dissector
45°, 8...
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·December 14, 2020
G7 HI-WALL E1 LINER 36MM E
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·June 4, 2018
G7 NEUTRAL E1 LINER 36MM E
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·June 4, 2018
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 16, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 14, 2008
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 26, 2013
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·October 15, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020