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BioHorizons Implant Systems Inc

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile recall (Z-0391-2016)BioHorizons Implant Systems Inc2015-12-07
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical i recall (Z-1605-2015)BioHorizons Implant Systems Inc2015-05-12
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHori recall (Z-1058-2014)BioHorizons Implant Systems Inc2014-02-20
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35 recall (Z-0561-2013)BioHorizons Implant Systems Inc2012-12-19
Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL recall (Z-0562-2013)BioHorizons Implant Systems Inc2012-12-19
Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiate recall (Z-0321-2011)BioHorizons Implant Systems Inc2010-11-04
Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Bioho recall (Z-0801-2007)BioHorizons Implant Systems Inc2007-05-11
BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, recall (Z-0692-2007)BioHorizons Implant Systems Inc2007-04-13
BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Bir recall (Z-0693-2007)BioHorizons Implant Systems Inc2007-04-13
BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmin recall (Z-0694-2007)BioHorizons Implant Systems Inc2007-04-13
BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Bir recall (Z-1164-2007)BioHorizons Implant Systems Inc2007-04-13
BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants recall (Z-0252-2007)BioHorizons Implant Systems Inc2006-12-06
The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm recall (Z-0925-05)BioHorizons Implant Systems Inc2005-06-23
The Maestor System 225-312, Profile Abutment for Cement, 5mm recall (Z-0926-05)BioHorizons Implant Systems Inc2005-06-23

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Every clearance here is in the API, with alerts when new ones post.