231 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.

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

FDA Recall
Terminated ·Zeus Scientific Inc·Product code MID·June 22, 2001

Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

FDA Recall
Terminated ·Zeus Scientific Inc·Product code DHR·November 9, 2001

Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

FDA Recall
Terminated ·Zeus Scientific Inc·Product code LFX·February 24, 2000

Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

FDA Recall
Terminated ·Zeus Scientific Inc·Product code LJB·March 19, 2001

Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

FDA Recall
Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

Alsius CoolGard Temperature Regulation System

FDA Recall
Terminated ·Alsius Corporation·Product code NCX·November 9, 2005

Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

FDA Recall
Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

FDA Recall
Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

FDA Recall
Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

Alsius Cool Line Catheter, Model CL-2295AE

FDA Recall
Terminated ·Alsius Corporation·Product code NCX·January 1, 2007

Alsius Cool Line Catheter, Model CL-2295A

FDA Recall
Terminated ·Alsius Corporation·Product code NCX·January 1, 2007

Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.

FDA Recall
Terminated ·Bio-Rad Laboratories·January 7, 2008

Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display

FDA Recall
Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

MEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.

FDA Recall
Terminated ·Howmedica Osteonics Corp dba Stryker Craniomaxillofacial·Product code FTM·December 16, 2011

Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.

FDA Recall
Terminated ·Bio-Rad Laboratories·Product code LOM·September 5, 2007