29 results
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23ms
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Sources: EU EUDAMED, US FDA
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