FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,479 results for "antimicrobial"
241–264 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · JWY
bioMerieux, Inc.
Microbiology · 86d
Cleared May 25, 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
K170892 · JWY
Liofilchem S. R. L.
Microbiology · 59d
Cleared May 01, 2017
Remel Spectra ESBL
K162620 · JSO
Remel, Inc.
Microbiology · 223d
Cleared Mar 21, 2017
BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4-...
K163637 · LON
Becton, Dickinson Company
Microbiology · 88d
Cleared Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · LTT
Beckman Coulter, Inc.
Microbiology · 172d
Cleared Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
K170127 · JTN
Hardy Diagnostics
Microbiology · 60d
Cleared Mar 14, 2017
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
K163517 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
K163563 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Feb 22, 2017
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
K163298 · JWY
Liofilchem S. R. L.
Microbiology · 92d
Cleared Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
K161437 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · LON
bioMerieux, Inc.
Microbiology · 257d
Cleared Feb 01, 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Jan 24, 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K163006 · LON
bioMerieux, Inc.
Microbiology · 88d
Cleared Jan 12, 2017
VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
K161217 · LON
bioMerieux, Inc.
Microbiology · 258d
Cleared Dec 19, 2016
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
K162854 · JWY
Liofilchem S. R. L.
Microbiology · 68d
Cleared Nov 15, 2016
HardyCHROM ESBL
K160512 · JSO
Hardy Diagnostics
Microbiology · 265d
Cleared Oct 25, 2016
chromID MRSA
K162076 · JSO
bioMerieux, Inc.
Microbiology · 90d
Cleared Sep 30, 2016
Atteris Antimicrobial Skin Protectant
K161212 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 155d
Cleared Aug 24, 2016
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and...
K161313 · PND
Arrow International, Inc. (Subsidiary...
General Hospital · 106d
Cleared Jul 28, 2016
Atteris Antimicrobial Skin & Wound Cleanser
K160192 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 183d
Cleared Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227 · LON
bioMerieux, Inc.
Microbiology · 79d
Cleared Jul 12, 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
K161175 · JWY
Liofilchem S. R. L.
Microbiology · 77d
Cleared Jun 29, 2016
Xpert Carba-R
K160901 · POC
Cepheid
Microbiology · 89d
Cleared Jun 22, 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · JWY
Liofilchem S. R. L.
Microbiology · 190d