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"
577–600 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
K043237 · LON
bioMerieux, Inc.
Microbiology · 31d
Cleared Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
K042963 · LON
bioMerieux, Inc.
Microbiology · 47d
Cleared Dec 13, 2004
DAPTOMYCIN
K042392 · JWY
Ab Biodisk
Microbiology · 102d
Cleared Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
K042946 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared Dec 02, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4...
K042932 · LON
Becton, Dickinson & CO
Microbiology · 41d
Cleared Nov 22, 2004
BBLCHROMAGAR MRSA
K042812 · JSO
Becton, Dickinson & CO
Microbiology · 41d
Cleared Nov 19, 2004
ETEST FOR GEMIFLOXACIN
K042390 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Oct 21, 2004
COLLAGEN-ORC ANTIMICROBIAL MATRIX
K033523 · FRO
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 349d
Cleared Oct 07, 2004
PASCO MIC AND MIC/ID PANELS
K042331 · JWY
Pasco Laboratories, Inc.
Microbiology · 38d
Cleared Sep 29, 2004
BARDEX I.C. LATEX FOLEY CATHETER
K040658 · MJC
C.R. Bard, Inc.
Gastroenterology & Urology · 201d
Cleared Sep 14, 2004
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K042157 · JTN
Oxoid , Ltd.
Microbiology · 35d
Cleared Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
K041982 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Aug 12, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
K041572 · LON
Becton, Dickinson and Co.
Microbiology · 59d
Cleared Aug 05, 2004
ANTIMICROBIAL ALGINATE DRESSING
K041316 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 80d
Cleared Aug 03, 2004
PASCO MIC AND MIC/ID PANELS
K041776 · JWY
Pasco Laboratories, Inc.
Microbiology · 33d
Cleared Aug 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
K041384 · LON
Becton, Dickinson & CO
Microbiology · 70d
Cleared Jul 27, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE...
K041534 · JWY
Trek Diagnostic Systems, Ltd.
Microbiology · 49d
Cleared Jun 10, 2004
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED...
K033477 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 220d
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845 · LON
bioMerieux, Inc.
Microbiology · 68d
Cleared Jun 07, 2004
PASCO MIC AND MIC/ID PANELS
K041214 · JWY
Pasco Laboratories, Inc.
Microbiology · 28d
Cleared May 28, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
K033458 · LON
Becton, Dickinson & CO
Microbiology · 211d
Cleared May 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
K040716 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 25d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K033907 · LON
Becton, Dickinson & CO
Microbiology · 114d