11 results
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19ms
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Sources: EU EUDAMED, US FDA
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
FDA 510(k)
FDA Class 3
·Orthopedic
Stern EX Acid Etched Implant RP 4.0x8.5mm, DD, Biomain, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108679·The Sterngold Acid Etch Dental Implant System c...
Printed Lower Crown Pack for Herbst LL5 14mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199016260·
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490523561·DISTRACTOR 901-626 C-STYLE 14/8MM
LENSX LASER SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 7, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·January 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·November 10, 2010
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025