134 results · 26ms · Sources: EU EUDAMED, US FDA

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StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

FDA Recall
Open, Classified ·Nova Biomedical Corporation·Product code PZI·November 20, 2024

Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code IYE·May 25, 2022

DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011

DePuy Mitek Panalock Loop w/ Orthocord Catalog #222980 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011

LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

FDA Recall
Terminated ·Covidien Llc·Product code GEI·December 6, 2021

DePuy Mitek Lupine Loop Rapide w/ Orthocord Catalog #210711 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011

DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011

DePuy Mitek Panalock Loop, Lupine Anchor Catalog #210704 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.

FDA Recall
Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code MAI·October 31, 2011

Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit

FDA Recall
Terminated ·Taut, Inc.·Product code GBW·January 19, 2007

Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

FDA Recall
Terminated ·Psi Health Solutions·Product code MVV·April 26, 2007

Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

FDA Recall
Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT220 2.3mm (D) x 20.0 mm (L) STERILE.

FDA Recall
Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE

FDA Recall
Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.

FDA Recall
Terminated ·American Medical Systems, Inc.·Product code EZY·March 1, 2013

Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall
Terminated ·Nobel Biocare Usa Llc·Product code DZi·March 14, 2019

Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labled as follows: 3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DDK315 LOT Disposable Drill Kit with DT315 STERILE

FDA Recall
Terminated ·Implant Innovations, Inc.·Product code DZI·December 2, 2003

AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.

FDA Recall
Terminated ·American Medical Systems, Inc.·Product code EZY·March 1, 2013

Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall
Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall
Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

FDA Recall
Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019