699 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code LJW·April 25, 2008
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJW·September 7, 2016
Tracheotome
FDA classification
FDA Class 1
·Tracheotome
Electric wheelchair (JJW-7002, JJW-7003)
FDA 510(k)
FDA Class 2
·Physical Medicine
LAY LOW ENTERPRISES LLC
FDA registration
LAY LOW ENTERPRISES LLC·1 product·🇺🇸 United States
Power Wheelchair (JJW-6001)
FDA 510(k)
FDA Class 2
·Physical Medicine
JW ANDERSON
FDA registration
JW ANDERSON·1 product·🇬🇧 United Kingdom
So-Low Environmental Equip. Co.,Inc.
FDA registration
So-Low Environmental Equip. Co.,Inc.·1 product·🇺🇸 United States
Linear probe
FDA UDI
CHISON Medical Technologies Co., Ltd.·06945121409742·
Power Wheelchair
FDA UDI
ZheJiang J&J Mobility Co., Ltd·06976245015564·
Wolff's Law Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
IMTEC
FDA UDI
PARK DENTAL RESEARCH CORP·D769LEW0010·6mm Lew Passive Attachment
IMTEC
FDA UDI
PARK DENTAL RESEARCH CORP·D769LEW0040·11mm Lew Passive Attachment
IMTEC
FDA UDI
PARK DENTAL RESEARCH CORP·D769LEW0020·7.5mm Lew Passive Attachment
IMTEC
FDA UDI
PARK DENTAL RESEARCH CORP·D769LEW001A0·5mm Lew Passive Attachment
IMTEC
FDA UDI
PARK DENTAL RESEARCH CORP·D769LEW0030·9mm Lew Passive Attachment
JW NORTH AMERICA, INC.
FDA registration
JW NORTH AMERICA, INC.·1 product·🇺🇸 United States
JW NORTH AMERICA, INC.
FDA registration
JW NORTH AMERICA, INC.·1 product·🇺🇸 United States
PRECISION®
FDA Adverse Event
Malfunction
·LGW·Product code LGW·September 20, 2016
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
FDA 510(k)
FDA Class 2
·Cardiovascular