14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
FDA 510(k)
FDA Class 2
·Cardiovascular
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327543032·DELTA 1.7MM 2 HOLE PLATE, COUNTERSINK, 0.75MM
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
FDA 510(k)
FDA Class 2
·Microbiology
ACE SDS 3.75MM SCREW DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM
FDA Adverse Event
Malfunction
·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015
CAIMAN DISP INSTR ARTICULAT D:12/240MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 16, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 3, 2013
MATRISTEM WOUND MATRIX
FDA Adverse Event
Injury
·ACELL INC.·Product code KGN·August 21, 2014
CONSULTA CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·May 18, 2011
CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2025
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