12 results
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18ms
·
Sources: EU EUDAMED, US FDA
PEGASUS
FDA 510(k)
FDA Class 2
·Radiology
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837041014·5.0mm SOLSTICE® Occipital Bone Screw T15, 9mm
ELMED
FDA UDI
ELMED INCORPORATED·00842180159396·Brooks Style” non-sterile, reusable, medical-gr...
2D TOF ANGIOGRAHY MEASURING FUNCTION
FDA 510(k)
FDA Class 2
·Radiology
DIGITCARE I.V. START KIT
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Zimmer, Inc.·00889024077737·
NA
FDA UDI
Zimmer, Inc.·00889024077744·
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 23, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 21, 2010
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013
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
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022