32 results
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86ms
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Sources: EU EUDAMED, US FDA
Precision Medical Devices, LLC
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·2 Devices·1 Importer
PRECISION MEDICAL DEVICES, LLC
FDA registration
PRECISION MEDICAL DEVICES, LLC·2 products·🇺🇸 United States
T-RING FLEX
Device
EU MDR
·
Eu Md Class 1
·Precision Medical Devices, LLC·On the market
T-Ring
Device
EU MDR
·
Eu Md Class 1
·Precision Medical Devices, LLC·On the market
T-RING FLEX Digit Tourniquet
FDA UDI
PRECISION MEDICAL DEVICES, LLC·00869193000057·The T-RING FLEX is a non-pneumatic tourniquet f...
T-RING Digit Tourniquet
FDA UDI
PRECISION MEDICAL DEVICES, LLC·10869193000016·The T-RING is a non-pneumatic tourniquet for di...
Topica Laceration Closure Tray
FDA UDI
PRECISION MEDICAL DEVICES, LLC·00869193000088·The Topical Laceration Closure Tray contains ev...
T-STRIP
FDA UDI
PRECISION MEDICAL DEVICES, LLC·00869193000002·The T-Strip is a 2.0 X 7.5 cm porous mesh wound...
T-RING
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Precision Medical Devices, LLC·2 devices
Atlantico Systems, Ltd.
Authorized representative
🇮🇪 Ireland·10 Manufacturers·165 Devices
AMASSE BIO-FLUID DETECTION DEVICE
FDA Adverse Event
Injury
·OPANS, LLC.·Product code OQS·April 25, 2023
Arthrone Oy
Importer
🇫🇮 Finland·7 Manufacturers
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
FDA Recall
Terminated
·Pro Trainers' Choice Company·Product code ILO·April 18, 2011
MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
FDA Recall
Terminated
·Hemostatix Medical Technologies LLC·Product code GEI·July 27, 2010
HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
FDA Recall
Terminated
·Hemostatix Medical Technologies LLC·Product code GEI·July 27, 2010
MedNet EC-REP C IIb GmbH
Authorized representative
🇩🇪 Germany·36 Manufacturers·989 Devices
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP
FDA Recall
Open, Classified
·Alcon Research, LLC·Product code LRO·March 10, 2023
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices