34 results
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22ms
·
Sources: EU EUDAMED, US FDA
VABRA ASPIRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACUMED
FDA UDI
Acumed LLC·10806378045110·ARH Std & Optional Trial Caddy Base
Zavation
FDA UDI
Zavation LLC·00842166112339·Z-Link Lumbar Spacer 8deg 33mmx17
Zavation
FDA UDI
Zavation LLC·00842166112346·Z-Link Lumbar Spacer 8deg 33mmx19
Zavation
FDA UDI
Zavation LLC·00842166112308·Z-Link Lumbar Spacer 8deg 33mmx11
Zavation
FDA UDI
Zavation LLC·00842166112322·Z-Link Lumbar Spacer 8deg 33mmx15
Zavation
FDA UDI
Zavation LLC·00842166112315·Z-Link Lumbar Spacer 8deg 33mmx13
LOVE GUARD MALE LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYLE SMARTIP
FDA 510(k)
FDA Class 1
·Dental
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 10, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 10, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 10, 1998
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 8, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 10, 2010
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code FGE·May 24, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only, For single use only --- Common Name: Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010