10,000 results
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83ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMM Ultrasonic Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
EMM EQUIPMENT COVER-POLYTHYLENE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGICAL GOWN REINFORCED XL FULLY AAMI I.V.
FDA Adverse Event
Malfunction
·EXACT MEDICAL MANUFACTURING (EMM)·Product code KKX·May 24, 2013
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OXFORD FIXED LATERAL BRG E5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2020
CURVED PELVIC OSTEOTOME 20MM WIDTH
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code EMM·March 8, 2013
OBWEGESER INTERDENTAL OSTEOTOME, 6.5MM, 15.5CM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code EMM·August 7, 2009
QWIX FIXATION SCREW - EMM DIAMETER X 22MM LENGTH
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES SERVICES SAS·Product code HWC·November 16, 2010
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
OXF UNI TIB TRAY SZ D LM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 24, 2019
OXF ANAT BRG LT MD SIZE 3 PMA MED SZ 3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 24, 2019
OXF UNI TIB TRAY SZ C LM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 1, 2019
OXF PKS ANAT MEN BRG UHMWPE LT MED SZ 4
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·July 1, 2019
EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
OXF ANAT BRG RT MD SIZE 6 PMA MED SZ 6
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 25, 2019
Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021