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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
1921–1944 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 58d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820 · JWY
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822 · JWY
Dade Behring, Inc.
Microbiology · 56d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
K020627 · LTT
Dade Microscan, Inc.
Microbiology · 69d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937 · JWY
Dade Microscan, Inc.
Microbiology · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037 · JWY
Dade Behring, Inc.
Microbiology · 35d
Cleared May 01, 2002
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
K020576 · NIJ
Id Biomedical Corp.
Microbiology · 69d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL -...
K020686 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748 · JWY
Ab Biodisk
Microbiology · 53d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · JWY
Dade Microscan, Inc.
Microbiology · 65d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · LTT
Dade Microscan, Inc.
Microbiology · 59d
Cleared Apr 26, 2002
BACT/ALERT SN CULTURE BOTTLE
K021123 · MDB
bioMerieux, Inc.
Microbiology · 18d
Cleared Apr 22, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN...
K020397 · LON
Dade Behring, Inc.
Microbiology · 75d
Cleared Apr 19, 2002
BACTEC MGIT 960 SIRE KITS
K014123 · MJA
Becton, Dickinson & CO
Microbiology · 123d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · MDB
bioMerieux, Inc.
Microbiology · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · MDB
bioMerieux, Inc.
Microbiology · 28d
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · MDB
bioMerieux, Inc.
Microbiology · 27d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020319 · LON
Dade Behring, Inc.
Microbiology · 77d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE...
K020506 · LON
Dade Microscan, Inc.
Microbiology · 61d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · MDB
bioMerieux, Inc.
Microbiology · 35d
Cleared Apr 04, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K020323 · LON
Becton, Dickinson & CO
Microbiology · 79d