Company
Greatbatch Medical
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
20recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2017 | Greatbatch Medical Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059). Terminated |
HTQ | None listed |
| Feb 15, 2017 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve).
The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter Terminated |
DYB | K130559 |
| Nov 29, 2016 | Greatbatch Medical Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #:
Tl0600 ~ MMP3100CHA04
T10491 MIMP3100CHA04
T12230 M2M1P3100CHA04
T15752 ~MMP3100CHA04
T15949 ~MMP3100CHA04
T17238 MMP3100CH Terminated |
HWA | None listed |
| Nov 18, 2016 | Greatbatch Medical Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR.
The radiopaque Stiffer Coaxial Micro-Introd Terminated |
DYB | K071574 |
| Nov 11, 2016 | Greatbatch Medical ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 Terminated |
DYB | K072248 |
| Oct 19, 2016 | Greatbatch Medical Offset Reamer Handle, T5766
Product Usage:
The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing su Terminated |
LXH | None listed |
| Apr 26, 2016 | Greatbatch Medical Torque Limiting Adapter:
Torque Limiting Attachment, Non Sterile, Distributed by Zimmer.
PRECIMED, Torque Limiting Adaptor, Non Sterile..
Customer Number/Model:
00-2360-080-00 T10232, T116245 T Terminated |
HWE | None listed |
| Apr 26, 2016 | Greatbatch Medical Torque Limiting Screwdriver:
Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only.
PRECIMED, Non Sterile.
Zimmer, Non Sterile, Rx Only.
Screwdriver:
Customer Number/Model:
804-03-03 Terminated |
HXX | None listed |
| Apr 26, 2016 | Greatbatch Medical Torque Limiting Handle:
PRECIMED, T-Handle Torque, Non Sterile.
Handle:
Customer Number/Model:
MCL120014 T14000, TLT911-50-S20 TLT911-50-S20,
TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 T Terminated |
HWE | None listed |
| May 13, 2014 | Greatbatch Medical Coaxial Micro-Introducer Kit.
Greatbatch Part Number/Bard Access Systems Order Number/Part Description
10636-001
8004011
Kit Coax 10 Pack 4FR Bard
10636-002
8005011
Kit Coax 10 Pack 5FR Bard
1063 Terminated |
DYB | K990705 |
| Mar 6, 2014 | Greatbatch Medical Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, Terminated |
HWA | None listed |
| Jun 27, 2013 | Greatbatch Medical Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14 Terminated |
DYB | K110051 |
| Jan 30, 2013 | Greatbatch Medical 45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031.
Model #:
P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU2600 Terminated |
LXH | None listed |
| Dec 22, 2012 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou Terminated |
DYB | K101784 |
| Oct 24, 2012 | Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou Terminated |
DYB | K101784 |
| Sep 26, 2012 | Greatbatch Medical Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Med Terminated |
DRA | K112541 |
| Nov 2, 2010 | Greatbatch Medical enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been Terminated |
DTB | None listed |
| Aug 27, 2010 | Greatbatch Medical Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Med Terminated |
DYB | K093232 |
| Dec 29, 2009 | Greatbatch Medical Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by: Enpath Medical, Inc., 2300 Berkshire L Terminated |
DTB | K925099 |
| Dec 29, 2009 | Greatbatch Medical Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. Terminated |
DTB | K870562 |