17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Comprehensive Reverse Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414640540·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414640847·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414640397·Automatic Disposable Biopsy Needle
NUVASIVE COROENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RELAY POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082840·Interbody Fusion Device, 18mm (W), 16mm (D), 11...
Unison™-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468075446·Stand-Alone Cervical Interbody Fusion Device
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082772·Interbody Fusion Device, 18mm (W), 16mm (D), 11...
Unison™-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468077471·Trial
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468081447·Trial, 18mm (W), 16mm (D), 11mm (H), 7° Lordosis
Unison®-C Anterior Cervical Fixation System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468082000·Rasping Trial, 18mm (W), 16mm (D), 11mm (H), 7°...
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code LTK·June 21, 2013
HYDRATOME¿ RX 44
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·July 27, 2011
WINGSPAN STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION·Product code NJE·September 29, 2008
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025