18 results · 23ms · Sources: EU EUDAMED, US FDA

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Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER

FDA 510(k)
FDA Class 2 ·General Hospital

SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RADIUS ROD PERSUADER

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·October 14, 2008

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013

TOTAL ASR ACET IMP SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·August 12, 2011

TOTAL ASR ACET IMP SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·August 12, 2011

DEPUY ASR XL FEM IMP SIZE 41

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KXA·August 19, 2013

ASR TAP SLV ADAP 11/13 +6

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·August 19, 2013

DEPUY ASR XL FEM IMP SIZE 41

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KXA·August 19, 2013

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

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