30 results · 14ms · Sources: EU EUDAMED, US FDA

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Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

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

VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.

FDA Recall
Terminated ·Biomerieux Inc·Product code LTW·June 2, 2011

AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995

FDA Recall
Terminated ·Cardinal Health·Product code FYA·January 11, 2020

VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

FDA Recall
Terminated ·Biomerieux Inc·Product code LTW·February 18, 2013

Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

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

PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

FDA Recall
Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

FDA Recall
Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

FDA Recall
Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.

FDA Recall
Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXL·January 4, 2008

Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.

FDA Recall
Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010

Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.

FDA Recall
Terminated ·Synthes, Inc.·Product code GXL·January 30, 2014