11 results
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18ms
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Sources: EU EUDAMED, US FDA
PP-1105 PARALLEL PIN
FDA 510(k)
FDA Class 2
·Dental
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331129391·Hemostatic clip applier, straight, ultra grip, ...
NUMED TYSHAK AND Z-MED PTV CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
BMT 360 TIBIAL TRAY 79MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 30, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INT'L., LTD.·Product code KWA·November 17, 2010
2520274-2013-00212
FDA Adverse Event
Injury
·SYNTHES·Product code MJO·January 9, 2013
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024