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

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KRYSTALRAD 560 (FLAATZ 560)

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV

CoRoent

FDA UDI
Nuvasive, Inc.·00887517563569·CoRoent Ant TLIF PEEK, 10x12x28mm 4°

ILIZAROV

FDA UDI
Smith & Nephew, Inc.·03596010031372·THREADED ROD - SMALL BONE FIXATOR 100MM

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009090·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

CRP Reagent Kit

FDA UDI
MEDICA CORPORATION·00386100002244·Full Range C-Reactive Protein Reagent Kit for u...

VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX

FDA 510(k)
FDA Class 2 ·Anesthesiology

WH ACCU TEST PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

THORACENTESIS KIT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC·Product code JOL·May 1, 2013

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 17, 2014

XIA BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code NKB·April 12, 2011

VERTEBRAL BODY SPREADER-

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·May 29, 2020

CNS-6201A

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·September 1, 2021

CNS-6201A

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·December 5, 2021

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

FDA Enforcement
Class II ·Terminated·ConvaTec, Inc·March 9, 2016

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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025