15 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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FLOWCLAMP CAT.#1011 & 1012
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Two Striper
FDA UDI
ABRASIVE TECHNOLOGY, INC.·B868C8020091·Dental Root Canal Post
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008023140091·Rotary diamond instrument for dental application
Symmetry Micro
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482032220·Symmetry® Forceps, Micro, Straight, Tip Width 0...
Momentum
FDA UDI
Ulrich Medical Usa, Inc.·00810076338071·Offset Hook, Left, Medium
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
FDA 510(k)
FDA Class 2
·Anesthesiology
KARL STORZ
FDA Adverse Event
Injury
·KARL STORZ ENDOSCOPY·Product code KQT·January 21, 2004
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
INTERMITTENT
FDA Adverse Event
Injury
·UNOMEDICAL S.R.O.·Product code KOD·May 30, 2019
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 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
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013