14 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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AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
FDA 510(k)
FDA Class 2
·Cardiovascular
Delta
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327594935·Twist drill hex end
Medline
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389028018·FENESTRATED DRAPE, 24 X 36
K-DEFIB/PACE, MODEL KDP-60A
FDA 510(k)
FDA Class 3
·Cardiovascular
CYNOSURE PHOTOGENICA VL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPINNING SPIROS® CLOSED MALE LUER, RED CAP
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·November 4, 2025
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
PEN NDL 32G 4MM PRO
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 28, 2020
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·May 3, 2013
CORMET RESURFACING
FDA Adverse Event
Injury
·CORIN LTD.·Product code NXT·September 2, 2014
MERIT CUSTOMER KIT
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·May 11, 2011
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Enforcement
Class II
·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012
Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
FDA Recall
Terminated
·Plus Orthopedics USA·Product code KTT·February 22, 2006
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