18 results
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52ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lark Technologies, Inc
FDA UDI
Lark Technologies, Inc.·00860008199133·SCALE, STAND-ON, PATIENT. A stand-on patient sc...
Lark Technologies, Inc
FDA UDI
Lark Technologies, Inc.·00860008199140·Scale, Stand-on, patient. A stand-on patient sc...
Lark Technologies
FDA UDI
Lark Technologies, Inc.·00860008199102·Digital monitor intended for use in measuring b...
JK Bariatric Beds, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
JK Bariatric Beds, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code FNM·March 18, 2014
Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.
FDA Recall
Terminated
·Zimmer Inc.·Product code LPH·May 29, 2009
Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-25.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.
FDA Recall
Terminated
·Mainline Technology, Inc.·Product code JHI·August 18, 2008
Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Recall
Terminated
·O-Two Medical Technologies, Inc.·Product code NAE·September 30, 2015