14 results · 23ms · 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.

CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005

FDA 510(k)
FDA Class 2 ·Cardiovascular

DELTA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327543032·DELTA 1.7MM 2 HOLE PLATE, COUNTERSINK, 0.75MM

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6

FDA 510(k)
FDA Class 2 ·Microbiology

ACE SDS 3.75MM SCREW DENTAL IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP AP & CO. KG·Product code GEI·March 27, 2015

CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 6, 2015

CAIMAN DISP.INSR.ARTICULAT.D:12 / 240MM

FDA Adverse Event
Malfunction ·AESCULAP AG& CO. KG·Product code GEI·April 15, 2015

CAIMAN DISP INSTR ARTICULAT D:12/240MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GEI·April 16, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 3, 2013

MATRISTEM WOUND MATRIX

FDA Adverse Event
Injury ·ACELL INC.·Product code KGN·August 21, 2014

CONSULTA CRT-D

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NIK·May 18, 2011

CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code GEI·July 28, 2014

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2025

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022