20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
FDA 510(k)
FDA Class 2
·Dental
I-neb
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730000954·I-neb PH Middle East Unit.
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006052·2600 MED 2WAY NRBV 1.375/1.125
Lateral Disc Prep
FDA UDI
Life Spine, Inc.·00190837089658·
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08809282816871·
Tulip Adjuster
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068707·
RADIOFIX
FDA 510(k)
FDA Class 2
·Orthopedic
RADIOLOGICAL IMAGE PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235410·Universal Driver
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 25, 2019
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 8, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
AWL Ø2 ANGL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 7, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·February 4, 2022
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 14, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
TEOSYAL RHA 4
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·January 10, 2022
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021