11 results · 27ms · 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.

PORT ACCESS INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

Bosworth Trim

FDA UDI
Harry J Bosworth Company·H66809219011·3 oz PEMA C&B Pwd, light

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756022521·Hip Pillow, Abduction

TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020

TROJAN PLEASURE PACK LUBRICATED CONDOMS

FDA Adverse Event
Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

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

TI-MAX Z45

FDA 510(k)
FDA Class 1 ·Dental

7700

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·December 8, 2010

AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWP·January 15, 2013

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·July 9, 2014

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

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