GZB
FIXATE TISSUE BAND
- Advisory panel
- Neurology
- Total cleared
- 139
Adverse events under product code GZB
product code GZB- Death
- 4
- Injury
- 1,879
- Other
- 2
- Total
- 1,885
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GZB
1–100 of 139- K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- K221376 — Nalu Neurostimulation System
- K203547 — Nalu Neurostimulation System
- K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
- K201618 — Nalu Neurostimulation SCS system
- K191466 — SandShark Injectable Anchor (SIA) System
- K190960 — Nalu Lead Blank (50cm)
- K182720 — Freedom Spinal Cord Stimulator (SCS) System
- K183047 — Nalu Neurostimulation System
- K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
- K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
- K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- K162161 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
- K160600 — Freedom Spinal Cord Stimulator System
- K150924 — A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
- K150517 — Freedom Spinal Cord Stimulator System
- K141399 — FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
- K140272 — SWIFT-LOCK ANCHOR
- K130545 — MULTI LEAD TRIAL CABLE
- K123299 — MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
- K113611 — RAPID PROGRAMMER
- K113805 — FIXATE TISSUE BAND
- K113400 — FIXATE TISSUE BAND
- K112214 — OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
- K112849 — FIXATE TISSUE BAND
- K111462 — FIXATE TISSUE BAND
- K102523 — MULTI-LEAD TRIALING CABLE MODEL 355531
- K092371 — SWIFT-LOCK ANCHOR, MODEL 1192
- K091993 — RAPID PROGRAMMER, VERSION 3.3.0
- K090907 — PENTA LEAD KITS, MODELS: 3227-3234
- K081208 — CINCH ANCHOR, MODEL 1194
- K072462 — WIDE SPACED QUATTRODE LEADS
- K070847 — TRIAL CABLE, 3009
- K063080 — TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
- K062041 — MODEL 3875 1 X 8 SC TEST STIMULATION LEAD
- K053250 — ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
- K052374 — RAPID PROGEAMMER 3.0
- K052418 — AXXESS BUTTERFLY ANCHOR
- K051773 — MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
- K050922 — ANS SCS ACCESSORY KIT
- K050633 — TRIAL CABLE RETENTION CLIP
- K040568 — POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
- K040609 — RAPID PROGRAMMER
- K033757 — MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
- K033429 — LAMITRODE SPINAL CORD STIMULATION LEADS
- K033016 — PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892
- K032751 — MODIFICATION TO RENEW LEAD EXTENSION
- K032034 — ANS AXXESS PERCUTANEOUS LEAD
- K032349 — PLACER
- K032561 — RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
- K030461 — A127 LEAD EXTENSION
- K030674 — MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
- K030118 — RAPID PROGRAMMAR
- K022222 — LAMITRODE S-SERIES (S4 AND S8) LEADS
- K021518 — PAINDOC
- K013120 — PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
- K013063 — GRIP LOCK ANCHOR, MODEL 411374
- K010300 — MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
- K010008 — AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
- K011584 — MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
- K000445 — MEDTRONIC MODEL 7499 EXTENSION
- K994097 — MEDAMICUS EPIDURAL INTRODUCER
- K992946 — RENEW RECEIVER
- K991784 — RENEW LEAD EXTENSION
- K990469 — LAMITRODE LEADS
- K990104 — MEDTRONIC MODEL 7495 EXTENSION KIT
- K972906 — MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)
- K971756 — MEDTRONIC MODEL 3998 LEAD
- K972043 — MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
- K964172 — MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
- K953742 — BIFURCATED Y-EXTENSION
- K960728 — ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)
- K955291 — DUALSCREEN
- K954886 — MODEL NOS. 7495 AND 501826 EXTENSIONS
- K941342 — PAIN DOC
- K952459 — MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL
- K943537 — MODEL 3470 X-TREL RF RECEIVER
- K934065 — MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM
- K950127 — ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
- K945103 — TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)
- K930536 — NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC
- K930498 — NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
- K940416 — NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
- K936099 — NEUROLOGICAL LEAD ACCESSORIES
- K934938 — TEMPORARY SCREENING LEAD/CATHETER KIT
- K932202 — MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT
- K932948 — MEDTRONIC MODEL 3625 SCREENER SYSTEM
- K930242 — INTRODE INT-8
- K921319 — NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30
- K923931 — MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
- K924522 — MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
- K923567 — MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD
- K921558 — MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS
- K913993 — MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS
- K913934 — MEDTRONIC MODEL 3586 RESUME LEAD
- K914433 — MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS
- K912764 — MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT
- K913442 — MEDTRONIC 3625 SCREENER SYSTEM
- K905569 — ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
- K905402 — ANTIGENZ CHLAMYDIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.