82 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EJF·January 14, 2020
Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
FDA Recall
Terminated
·Ortho Organizers, Inc.·Product code EJF·April 2, 2019
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EJF·April 24, 2012
Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code EJF·February 8, 2013
Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code EJF·March 25, 2014
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
FDA Recall
Terminated
·Ortho Organizers, Inc.·Product code EJF·April 2, 2019
Titanium Orthos Bracket
FDA Recall
Terminated
·Ormco Corporation·Product code EJF·November 18, 2004
Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco Corporation·Product code EJF·February 13, 2009
ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM
FDA Recall
Terminated
·ACMI CORPORATION·Product code FFK·April 30, 2004
ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM
FDA Recall
Terminated
·ACMI CORPORATION·Product code FFK·April 30, 2004
ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM
FDA Recall
Terminated
·ACMI CORPORATION·Product code FFK·April 30, 2004
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·March 21, 2018
NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch. Used to create an atrial septal defect in the heart.
FDA Enforcement
Class II
·Terminated·Baylis Medical Corp *·November 16, 2016
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
FDA Recall
Terminated
·Medela Inc. EF Division·Product code FMF·February 13, 2015
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.
FDA Enforcement
Class II
·Terminated·Medela Inc. EF Division·March 18, 2015
37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
FDA Recall
Terminated
·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EBF·March 31, 2011
PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008
PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite
FDA Recall
Terminated
·Kerr Corp·Product code EBF·September 5, 2008