19 results
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6ms
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Sources: EU EUDAMED, US FDA
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Enforcement
Class II
·Ongoing·EMPATICA SRL·November 1, 2023
Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 6, 2016
CBS micro, countersink, cannulated, AO, Item Number ST503004541
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS high, countersink, cannulated, AO, Item Number ST503004542
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS high, countersink, cannulated, AO, Item Number 503004542
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS 7.5 tap, cannulated, AO, Item Number 503002041
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS micro, countersink, cannulated, AO, Item Number 503004541
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS high, countersink, cannulated, round-shaft, Item Number 503004342
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·May 24, 2017
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·December 24, 2014
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 2, 2014
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
FDA Enforcement
Class II
·Terminated·JAS Diagnostics Inc.·July 12, 2017
TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·August 10, 2016
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
FDA Enforcement
Class II
·Terminated·Jas Diagnostics/Drew Scientific·May 4, 2016