19 results
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30ms
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Sources: EU EUDAMED, US FDA
BIOREHAB SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517275882·CoRoent Large MP Trial, 10x9x28mm 8°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780750·LEVAMED ACTIVE ANKLE SUP SLVR L III
INTER FIX™ RP Threaded Fusion Device
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978957456·18X23 INTERFIXRP FUSION DEVICE
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112230·Tap, 5.50mm, Cannulated, Fixed Sleeve
LINKMAX
FDA 510(k)
FDA Class 2
·Dental
SPAZZ
FDA 510(k)
FDA Class 1
·Physical Medicine
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
HYDRELLE
FDA Adverse Event
Other
·ANIKA THERAPEUTICS, INC.·Product code LMH·February 24, 2011
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·February 8, 2008
TPRLC XR MP T1 PPS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021
SYRINGE 1.0ML 31GA 8MM
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 4, 2021
TPRLC 133 FP TYPE1 PPS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021
TPRLC XR MP T1 PPS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021
TPRLC XR T1 PPS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JDI·February 4, 2021
TPRLC 133 MP TYPE1 PPS HO
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWL·February 4, 2021
TPRLC 133 MP TYPE1 PPS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWL·February 4, 2021
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
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024