372 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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 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

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

HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

FDA Recall
Terminated ·Instrumentation Laboratory Co.·Product code GJS·April 9, 2013

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

SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative.

FDA Recall
Terminated ·Patterson Dental Supply, Inc.·Product code EBF·October 15, 2010

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

FDA Recall
Terminated ·Cosmedent, Inc.·Product code KLE·September 28, 2017

TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia

FDA Recall
Terminated ·Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia·Product code KGO·December 18, 2006

Solara 2G manual wheelchair.

FDA Recall
Terminated ·Invacare Corporation·Product code IOR·June 27, 2006

TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

Invacare 2G Tarsys Seating System, Model 2GR.

FDA Recall
Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

Invacare 2G Tarsys Seating System, Model 2GT.

FDA Recall
Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

Invacare 2G Tarsys Seating System, Model 2GTR.

FDA Recall
Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

3G Storm Series Power Wheelchair with Power Tilt Option.

FDA Recall
Terminated ·Invacare Corporation·Product code ITI·October 11, 2005

IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·January 2, 2018

ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

FDA Recall
Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.

FDA Recall
Terminated ·Invacare Corporation·Product code IOR·September 10, 2012

Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

FDA Recall
Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

FDA Recall
Terminated ·Axonics Modulation Technologies, Inc.·Product code LNM·June 3, 2021