26 results · 23ms · 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.

Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.

FDA Recall
Terminated ·Surgical Appliance Industries·Product code FQL·October 7, 2011

Truform Therapeutic Classic Medical Style Compression Stockings 20-30 mmHG, Truform Therapeutic Classic Medical Style Compression Stockings 30-40 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.

FDA Recall
Terminated ·Surgical Appliance Industries·Product code FQL·October 7, 2011

Endocoupler 18 MM F.L, Autoclavable Catalog Number: 7207905, 7207905S

FDA Recall
Terminated ·Smith And Nephew, Inc. Endoscopy Division·Product code FXM·February 19, 2004

Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

FDA Recall
Terminated ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019

Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system

FDA Recall
Terminated ·Cook Inc.·Product code FCL·April 15, 2016

Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

FDA Recall
Terminated ·Pentax of America Inc·Product code EQL·December 12, 2016

Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. 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 Recall
Terminated ·Pentax Medical Company·Product code EQL·April 6, 2016

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps UPN/Catalog Number: MOO513330 The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). Single packaged units of M00513330 are not sold individually.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FCL·May 6, 2010

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FCL·May 6, 2010

Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FCL·May 6, 2010

Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.

FDA Recall
Terminated ·Ivoclar A. G. Fl-9494 Schaan Liechtenstein·Product code EBC·October 7, 2015

RAD SOURCE RS 3000 Blood Irradiator Three Bag Option

FDA Recall
Terminated ·Rad-Source Technologies, Inc. 20283 State Rd. 7 Suite 107 Boca Raton FL 33498·Product code MOT·June 1, 2002

Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices

FDA Recall
Terminated ·Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297·Product code KHE·March 21, 2011

Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices

FDA Recall
Terminated ·Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297·Product code KHE·March 21, 2011

Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices

FDA Recall
Terminated ·Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297·Product code KHE·March 21, 2011

Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices

FDA Recall
Terminated ·Alere North Americal 30 S Keller Rd Ste 100 Suite 100 Orlando FL 32810-6297·Product code KHE·March 21, 2011