20 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FPT NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
artegral
FDA UDI
Merz Dental GmbH·D7091970010·anteriors; shade A1; mould BIL
PCRopsis
FDA UDI
ENTOPSIS, LLC·B55059700100·PCRopsis™ Lysis Beads (10 grams, bulk) facilita...
Modulus Expandable
FDA UDI
Nuvasive, Inc.·00195377042149·MOD-EX XLIF Adapter, Slap Hammer
PIRANHA
FDA UDI
Richard Wolf GmbH·04055207023501·ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM for MOR...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700101·Mand. 2. Molar band W-Fit right 10
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697292·PAI Dental Implant Ø4.2mm L16mm
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700100501·Mand. 2. Molar band W-Fit right 10
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700100101·Mand. 2. Molar band W-Fit right 10
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89700100051·Mand. 2. Molar band W-Fit right 10
Filler, Bone Void, Non-Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
FDA 510(k)
FDA Unclassified
·Unknown
Salle Intraoperative Pyeloplasty Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·NORIAN SRS CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·NORIAN SRS CEMENT
Bone Cement
FDA Pre-Market Approval
FDA Class 2
·NORIAN SRS BONE CEMENT
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·February 20, 2013
MITEK VAPR P90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·January 14, 2011
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 11, 2013
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019