Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Synvasive Technology with 10 510(k) clearances and 4 device recalls. The most recent is a device recall dated Jul 27, 2018: ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or car….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 27, 2018 | ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Class II · Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. | Device recalls |
| Dec 8, 2015 | Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 anClass II · Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specific | Device recalls |
| Apr 2, 2013 | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive TechnologClass II · Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch sa | Device recalls |
| Mar 14, 2013 | The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Class II · Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. | Device recalls |
| Mar 22, 2011 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZESK093046 · ONN | 510(k) clearances |
| Apr 4, 2007 | ELIBRA DYNAMIC KNEE BALANCERK070108 · ONN | 510(k) clearances |
| Aug 26, 1997 | SURGICAL BURS AND SURGICAL DRILL BITSK972508 · HWE | 510(k) clearances |
| Sep 23, 1996 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PINK961522 · HTY | 510(k) clearances |
| Aug 18, 1995 | POWERGRIP(TM) COMPRESSION FIXATION DEVICEK950009 · JDW | 510(k) clearances |
| Mar 10, 1995 | SPINALPLANEK934336 · HSZ | 510(k) clearances |
| Apr 15, 1994 | CEBOPLANEK933933 · HTZ | 510(k) clearances |
| Apr 7, 1994 | SYNVASIVE CERAMIC SUTTING BLOCKK930573 · LXI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
