19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Nitrile Glove Powder Free Blue
FDA 510(k)
FDA Class 1
·General Hospital
SOFTSILK CLEAR-TRAC
FDA UDI
Smith & Nephew, Inc.·00885554011395·SOFTSILK SCR 2.0 8X30 IN CANN LTX (1)
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777471·LUMBAMED PLUS FLEX PAD WM SILVER V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517296979·CoRoent® XL-XW, 10x26x45mm 10°
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721728·Cottle Double Hook 6" (15cm), two prongs, blunt...
Garrett Vessel Probe 21cm 2.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034047286·Garrett Vessel Probe 21cm 2.5mm
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLE T NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
Dilator, Vascular, acc. Garrett 21cm 2.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034047316·Dilator, Vascular, acc. Garrett
21cm 2...
Garrett Vascular Dilator 21cm 2.5mm
FDA UDI
Geister Medizintechnik GmbH·04057034047309·Garrett Vascular Dilator 21cm 2.5mm
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011
NXT CLEARVIEW
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS·Product code LJS·September 20, 2007
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code LKK·July 8, 2013
UNK COIL-THERMO MECHANICAL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, 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 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.
FDA Enforcement
Class II
·Terminated·Integrity Implants Inc.·December 14, 2022
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
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
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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