559 results
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Sources: EU EUDAMED, US FDA
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Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
FDA Recall
Terminated
·Mick Radio Nuclear Instr Inc·Product code IWF·March 30, 2005
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 8, 2015
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 28, 2016
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CFL·April 15, 2016
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·July 30, 2014
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Recall
Terminated
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code MAX·May 21, 2015
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
FDA Enforcement
Class III
·Terminated·AGFA Healthcare Corp.·August 20, 2014
RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.
FDA Recall
Terminated
·PerkinElmer LAS Inc·Product code GKA·September 14, 2004
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
FDA Recall
Terminated
·Permobil, Ab Arvaltsvagen 10·Product code ITI·September 1, 2017
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
FDA Enforcement
Class II
·Terminated·Permobil, Ab·October 11, 2017
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
FDA Recall
Terminated
·AGFA Healthcare Corp.·Product code IWZ·July 16, 2014
Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019