319 results · 12ms · Sources: EU EUDAMED, US FDA

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Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.

FDA Recall
Terminated ·Nonin Medical, Inc·Product code MUD·October 23, 2009

Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient Manufactured by: Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-936-5400 outside USA 866-800-7742 fax

FDA Recall
Terminated ·Integra LifeSciences Corporation·Product code MDD·March 11, 2016

BacT/ALERT FN Culture Bottles, Product Number 259793

FDA Recall
Terminated ·bioMerieux, Inc.·Product code MBD·February 16, 2007

Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA

FDA Recall
Terminated ·Integra LifeSciences Corp·Product code MDD·July 2, 2008

Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021

FDA Recall
Terminated ·Integra LifeSciences Corp·Product code MDD·January 16, 2009

MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90.*** Manufactured in USA*** MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90.***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA***MAKO SURGICAL CORP. 2555 Davie Road, Ft. Lauderdale, FL 33317.*** THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.

FDA Recall
Terminated ·Mako Surgical Corporation·Product code KQM·October 25, 2010

ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.

FDA Recall
Terminated ·Hummingbird Med·Product code KST·October 1, 2015

ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.

FDA Recall
Terminated ·Hummingbird Med·Product code KST·March 11, 2015

CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA. For use to support and aid in positioning a patient during radiologic and other medical procedures.

FDA Recall
Terminated ·Med Tec Inc·Product code IXQ·June 21, 2010

CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.

FDA Recall
Terminated ·Med Tec Inc·Product code IYE·August 31, 2009

ALLMED Huber Needles 22ga x .75 Straight Hub Needle - Bulk, Non-Sterile Model # M2275HS-NS Reorder # 55-2235 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

All Med Medical 20ga x 1.50" Winged Administration Set Model # M2015 Reorder # 50-2041

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

All Med Medical 19ga x .50" RA Hub Needle Model #M195H Reorder #55-1910 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set Model # MW191-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

All Med Medical 22ga x .50" RA Hub Needle Model #M225H Reorder #55-2210 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

All Med Medical 20ga x 1.5" Straight Hub Needle Model #M2015HS Reorder #55-2045 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set Model # MWS201 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

FDA Recall
Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010