12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DUKAL SKIN CLOSURE STRIP
FDA 510(k)
FDA Class 1
·General Hospital
VARIAX
FDA UDI
Stryker GmbH·04546540540270·Screw Rack for 3.5mm Bone Screws
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515239869·Lucae Dress Fcps, del, bay, 5 3/4"
Glover Bulldog
FDA UDI
KOROS U.S.A., INC.·10840199539571·Glover Bulldog Straight 5cm Jaw Length 1.8cm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310050·Probe, 1.5 inch Ball, Lenke, Curved, Black
EBA2 FEMORAL NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LUMEND FRONTRUNNER GW CTO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
2.4MM CORTEX SCREW SELF-TAPPING 38MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·January 28, 2013
PFC SIGMA/OV/DOME PAT 3PEG,38
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·December 14, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code BRZ·July 13, 2014
IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main Street, Hopkinton, NY 12965 --- The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212, Class II device.
FDA Recall
Terminated
·Numed Inc·Product code LIT·September 23, 2009
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013