21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
FDA 510(k)
FDA Class 2
·Anesthesiology
Smith and Nephew
FDA UDI
Provision·B504TC72101260·
Smith and Nephew
FDA UDI
Provision·00810041631923·
NA
FDA UDI
Smith & Nephew, Inc.·03596010493453·5.0 MM I.D. UNIVERSAL CANNULA, 76
...
Dilator, Vascular, acc. Garrett 19cm 3.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034046944·Dilator, Vascular, acc. Garrett
19cm 3...
Dilator, Vascular, acc. Garrett 19cm 3.0mm
FDA UDI
Geister Medizintechnik GmbH·04057034046951·Dilator, Vascular, acc. Garrett
19cm 3...
BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
MCKESSON CONSULT 120 URINE ANALYZER
FDA Adverse Event
Malfunction
·ACON LABORATORIES, INC.·Product code KQO·March 28, 2025
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 20, 2008
LOOP, CUTTING, COOK
FDA Adverse Event
Malfunction
·COOK MEDICAL·Product code FDC·July 29, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 8, 2013
MCKESSON CONSULT U120 URINE ANALYZER
FDA Adverse Event
Malfunction
·ACON LABORATORIES, INC.·Product code KQO·October 24, 2023
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.
FDA Enforcement
Class II
·Terminated·Integrity Implants Inc.·December 14, 2022
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014