10 results
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7ms
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Sources: EU EUDAMED, US FDA
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
FDA Enforcement
Class II
·Terminated·Owen Mumford USA, Inc.·April 8, 2015
Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 29, 2015
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
FDA Enforcement
Class II
·Ongoing·Brasseler USA I Lp·February 14, 2024
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
FDA Enforcement
Class II
·Terminated·Brasseler USA I Lp·December 11, 2019
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.
FDA Enforcement
Class II
·Terminated·Brasseler USA I Lp·February 5, 2020
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
FDA Enforcement
Class II
·Terminated·LW Scientific, Inc.·April 3, 2019
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips
FDA Enforcement
Class II
·Terminated·LW Scientific, Inc.·April 3, 2019
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
FDA Enforcement
Class II
·Terminated·LW Scientific, Inc.·April 3, 2019
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
FDA Enforcement
Class II
·Terminated·Covidien LLC·November 16, 2016