10,000 results
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258ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Wexler Surgical, Inc.
FDA UDI
WEXLER SURGICAL, INC.·M944NL072015SHE0·
SANO
FDA UDI
Beijing Sano Lasers S&T Development Co., Ltd.·06973511890085·The proposed device is a type of the most advan...
SANO
FDA UDI
Beijing Sano Lasers S&T Development Co., Ltd.·06973511890092·The proposed device is a type of the most advan...
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917024615·Personal Use Kit OC-Auto, for St. Elizabeth Phy...
SANO
FDA UDI
Beijing Sano Lasers S&T Development Co., Ltd.·06973511890061·The proposed device is a type of the most advan...
OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917027098·OC-Auto SENSOR io Personal Use Kit for St. Eliz...
Cryojet Plus (SHE-ACP001-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SANO
FDA UDI
Beijing Sano Lasers S&T Development Co., Ltd.·06973511890108·CO2 laser is monochromatic light with strong pe...
SANO
FDA UDI
Beijing Sano Lasers S&T Development Co., Ltd.·16973511890006·The Q-Switched Nd:YAG Laser is indicated for us...
SANO
FDA UDI
Beijing Sano Lasers S&T Development Co., Ltd.·06973511890078·Cryojet Plus is intended to minimize pain and t...
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CO2 Laser Therapy Systems (SHE-LSP003-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHE-LI TENS STIMULATOR MODEL SL-101 RX
FDA 510(k)
FDA Class 2
·Neurology
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
FDA 510(k)
FDA Class 2
·Microbiology
SHE
FDA Adverse Event
Malfunction
·TOSAMA D.O.O.·Product code HEB·December 14, 2017
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
FDA Enforcement
Class II
·Terminated·Haag-Streit USA Inc·September 26, 2012
Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code HPT·August 17, 2012
PATHWAY BALLOON EXPANDALB EURETERAL ACCESS SHE
FDA Adverse Event
Injury
·ONSET MEDICAL CORPORATION·Product code DYB·May 13, 2014
HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY-ALB·Product code LFL·March 6, 2002