13 results · 20ms · Sources: EU EUDAMED, US FDA

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Large Screws Range

FDA 510(k)
FDA Class 2 ·Orthopedic

B-P TOTAL HIP SYSTEM

FDA UDI
ENDOTEC, INC.·00814193024480·B-P MODULAR EXTENSION W/ULTRACOAT - 17 MM X 150 MM

PTS PANELS HDL CHOLESTEROL TEST STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 24, 2017

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

EON MINI IPG, 16-CHANNEL RECHARGEABLE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 6, 2011

HARMONIC ACE 23 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·September 5, 2008

TFNA FEM NAIL Ø10 R 125° L320 TIMO15

FDA Adverse Event
Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018

10MM/125 DEG TI CANN TFNA 200MM - STERILE

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018

PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

FDA Enforcement
Class II ·Ongoing·CP Medical Inc·April 26, 2017

Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

FDA Enforcement
Class II ·Terminated·Medtronic Navigation, Inc.·December 25, 2019

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018