17 results · 24ms · Sources: EU EUDAMED, US FDA

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DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can sit on top of. Part #E30006 - Spa Jet 2G; 220V,50/60Hz. 15A. This is the Spa Jet product without the 2 optional pedestals which the unit can sit on top of.

FDA Recall
Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.

FDA Recall
Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

DERMALIFE Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G;100V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 100V version which was produced specifically for our Japanese consignee to meet Japan's specialized 100V electrical requirements. Part #E30007-200 is: Spa-Feng Shui 2G;200V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 200V version which was produced specifically for our Japanese consignee to meet Japan's specialized 200V electrical requirements. Part #E30007-01 - Feng Shui 2G; Assay w/Pedestal. This is the Spa Feng Shui product including the 2 optional pedestals which the unit can sit on top of.

FDA Recall
Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above.

FDA Recall
Terminated ·Sybaritic, Inc·Product code IMB·June 22, 2007

Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South, Minneapolis, MN 55431.

FDA Recall
Terminated ·Sybaritic, Inc·Product code IMB·May 15, 2007

ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·October 20, 2015

JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code LZO·June 30, 2017

ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

REF 905581, 6.8 mm Lactoscrew 2#2 MB wI NDL, (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.

FDA Recall
Terminated ·Biomet, Inc.·Product code HWC·January 25, 2012

ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

FDA Recall
Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

FDA Recall
Terminated ·NEUSOFT MEDICAL SYSTEMS IMP &·Product code JAK·January 9, 2019

Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.

FDA Recall
Terminated ·Aperio Technologies Inc·Product code IBM·February 22, 2013

EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

FDA Recall
Terminated ·Richard-Allan Scientific Company·Product code IFB·June 4, 2018

SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.

FDA Recall
Terminated ·Separation Technology, Inc.·Product code IFB·March 13, 2013

ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

FDA Recall
Terminated ·Ameditech Inc·Product code DKC·August 18, 2020