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"
409–432 of 1,479
Search insights Median review: 66d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology
Cleared Nov 20, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE...
K082538 · LON
Becton, Dickinson & CO
Microbiology · 79d
Cleared Nov 12, 2008
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
K080503 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 261d
Cleared Oct 24, 2008
SENSITITRE VIZION
K081520 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Oct 06, 2008
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · JTN
Becton, Dickinson & CO
Microbiology · 56d
Cleared Oct 02, 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · JTN
Becton, Dickinson & CO
Microbiology · 52d
Cleared Oct 02, 2008
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · FMG
Elcam Medical Acal
General Hospital · 69d
Cleared Sep 24, 2008
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT...
K081363 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 132d
Cleared Sep 16, 2008
SILVERMED ANTIMICROBIAL SILVER HYDROGEL
K073019 · FRO
Argentis Biomedical Incorporated
General & Plastic Surgery · 327d
Cleared Sep 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST...
K081013 · LRG
Siemens Healthcare Diagnostics
Microbiology · 152d
Cleared Aug 28, 2008
SILVER ANTIMICROBIAL WOUND GEL
K073197 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 289d
Cleared Aug 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST -...
K081182 · JWY
Siemens
Microbiology · 105d
Cleared Aug 07, 2008
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
K073396 · FPA
B.Braun Medical, Inc.
General Hospital · 248d
Cleared Aug 04, 2008
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK...
K081289 · FPA
Baxter Healthcare Corp
General Hospital · 89d
Cleared Jul 24, 2008
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
K081325 · JWY
Ab Biodisk
Microbiology · 73d
Cleared Jun 27, 2008
DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG)
K080497 · FRO
Derma Sciences Canada, Inc.
General & Plastic Surgery · 126d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · JSO
Bio-Rad
Microbiology · 45d
Cleared May 28, 2008
THERABOND ANTIMICROBIAL BARRIER SYSTEMS
K073213 · FRO
Choice Therapeutics
General & Plastic Surgery · 196d
Cleared May 12, 2008
DORIPENEM 10UG BBL SENSI-DISC
K080998 · JTN
Becton, Dickinson & CO
Microbiology · 35d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Apr 23, 2008
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS
K073547 · FRO
Anacapa Technologies, Inc.
General & Plastic Surgery · 127d
Cleared Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML)...
K073589 · LON
Becton, Dickinson & CO
Microbiology · 76d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · LON
bioMerieux, Inc.
Microbiology · 44d