17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MS-30 LATERAL FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743724·ACHIMED ACHILLES SUPP SAND III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743663·ACHIMED ACHILLES SUPP SILVER III
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221231444·Unitek Miniature Twin MBT LR 1Bi -12T/2A DHk 02...
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837009915·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837010010·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837050771·10mmx20mmx13mm Plateau-P, 7 Degree Reverse Angle
POLARIS
FDA UDI
HNM TOTAL RECON LLC·00841742113562·POLARIS ø2.0mm Snap-Off Screw, Ti - (L)13mm
Phonak
FDA UDI
Phonak AG·07613275217726·Phonak Sky Q90-RIC (pure transparent)
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES
FDA 510(k)
FDA Class 2
·Dental
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
RUSCH EQUIPLITE MTL. DISP. MACINTOSCH BLADE, 2
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CAL·March 18, 2013
MACH1 GUIDE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·March 16, 2011
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020