21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125556·PowerChem Neoprene Exam Gloves, Extra Large
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293463·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049620·Steinmann Pins, Double trocar, 5/32-inch (4.0mm...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771013037·Steinmann Pins, Double trocar, 5/32-inch (4.0mm...
Steinmann pin w. double end trocarpoint 4.0mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM714650·Steinmann pin w. double end trocarpoint
4.0mm/...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484856·Steinmann pin w. double end trocarpoint _x000D_...
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 22, 2023
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·April 22, 2013
AVIATOR PLUS PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LIT·April 28, 2011
ENDOPATH EXCEL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·July 2, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000749;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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