17 results
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16ms
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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
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
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
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
FDA Enforcement
Class II
·Terminated·PMBS, LLC·April 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
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
FDA Enforcement
Class II
·Ongoing·NxStage MDS Corporation·March 6, 2024
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
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