22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MERCURY RHINOMANOMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
OMEGA
FDA UDI
Stryker GmbH·07613154482504·Basic Lag Screw Instrument Tray
OPTICS ONE
FDA UDI
MEDICAL TECHNIQUE, INC.·00815384022049·Generic Microscope/Laser/Camera Cover 42 x 120 ...
Marking Pen
FDA UDI
KATENA PRODUCTS, INC.·00841668113219·MARKING PEN FOR TREPHINE & PUNCH
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981142247·Mariner Instrument Tray 1, Base
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080000·TEMPLATE 902-120 20MM
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051778·.022/045 U6L TBT/NC 0T 5 OFF
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
FDA 510(k)
FDA Class 2
·Anesthesiology
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NA
FDA UDI
Exactech, Inc.·10885862548221·4 MM SHIM FOR SPACER BLOCK
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·August 1, 2018
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 30, 2014
POSTERIOR CHAMBER LENS
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 10, 2010
CUSTOM DEFINED DEVICE
FDA Adverse Event
EDWARDS LIFESCIENCES DR·Product code DXO·January 8, 2013
VANGUARD XP FEMORAL INTERLOK-LEFT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·December 15, 2017
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012