199 results · 16ms · 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.

ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic, syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. Distributed by Siemens, Healthcare, Concord, CA 94520 Radiation therapy

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 31, 2011

Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) "Catalog numbers: 300-50, 300-55 OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.

FDA Recall
Terminated ·Stryker Biotech·Product code OJZ·October 25, 2010

Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.

FDA Recall
Terminated ·Flower Orthopedics Corporation·Product code HWC·February 16, 2015

Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.

FDA Recall
Terminated ·Kimberly-Clark Corporation·Product code KNT·June 22, 2010

Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.

FDA Recall
Terminated ·Kimberly-Clark Corporation·Product code KNT·June 22, 2010

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

FDA Recall
Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·February 21, 2023

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

FDA Recall
Terminated ·AbbVie Inc.·Product code KNT·April 27, 2017

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

FDA Recall
Terminated ·AbbVie Inc.·Product code KNT·April 27, 2017

AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

FDA Recall
Terminated ·AbbVie Inc.·Product code KNT·April 27, 2017

UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 Variety of hip and knee implants and instruments, multiple uses.

FDA Recall
Terminated ·Orthopedic Alliance LLC·Product code JWH·February 20, 2013

Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. One single unit to a package. Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·December 22, 2010

22 French Ross Versa-PEG Complete Gastrostomy Kit, an Over-the-Wire PEG Method Featuring Tube Removal without Endoscopy (list # 50520).

FDA Recall
Terminated ·Abbott Laboratories·Product code LNO·November 12, 2004

TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

FDA Recall
Open, Classified ·TriMed Inc.·Product code LXH·September 28, 2018

Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.

FDA Recall
Terminated ·Disc Orthopaedic Technologies Inc·Product code NDH·December 11, 2002

CORFLO PEG Kit, Pull 16FR. Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.

FDA Recall
Terminated ·CORPAK MedSystems, Inc.·Product code KNT·February 3, 2017

Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill); Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·February 9, 2011

Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code MBH·March 22, 2017

CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.

FDA Recall
Terminated ·Avanos Medical, Inc.·Product code KNT·October 8, 2019

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

FDA Recall
Terminated ·Biomet, Inc.·Product code MBH·April 17, 2020

CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; Product Usage: CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.

FDA Recall
Terminated ·CORPAK MedSystems, Inc.·Product code KNT·February 3, 2017