11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORT ACCESS INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Bosworth Trim
FDA UDI
Harry J Bosworth Company·H66809219011·3 oz PEMA C&B Pwd, light
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756022521·Hip Pillow, Abduction
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TI-MAX Z45
FDA 510(k)
FDA Class 1
·Dental
7700
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·December 8, 2010
AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWP·January 15, 2013
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 9, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022