28 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BIOROOT RCS

FDA 510(k)
FDA Class 2 ·Dental

BENCO

FDA UDI
BENCO DENTAL SUPPLY CO.·00366975052797·

LINK Instruments - Impactors, extractors and insertion

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575032945·Orthopaedic implant inserter/extractor, reusabl...

ALEUTIAN Interbody Systems

FDA UDI
VB Spine LLC·10888857560703·Disc Spreader Size 6 mm

Portex

FDA UDI
ICU MEDICAL, INC.·15019517083910·

BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 18, 2023

VERTE-STACK SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Vasomedical-Biox™ 1306 Ultra Compact 12- Channel ECG Holter Recorder

FDA UDI
VASOMEDICAL, INC.·00817980020184·12 CH ECG Holter ULTRA Recorder

BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 27, 2023

Stablecut®

FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494695·

Stablecut®

FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494688·

Stablecut®

FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494701·

BOOMERANG PEEK FUSION DEVICE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011

Vasomedical-Biox™ Model 1306 12 CH Recorder - 10 Lead Patient Cable

FDA UDI
VASOMEDICAL, INC.·00817980020436·Model 1306 12 CH Recorder - 10 Lead Patient Cable

PFNA BLADE PERF L75 SST

FDA Adverse Event
Injury ·SYNTHES USA·Product code HSB·May 24, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 30, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 6, 2015

UNKNOWN_RECONSTRUCTIVE_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·October 15, 2014

DERMATOME BLADES

FDA Adverse Event
Injury ·ZIMMER SURGICAL, INC.·Product code GFD·October 10, 2023