FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97729–97752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
K961538 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM
K961539 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA SONNEI GROUP D ANTISERUM
K961540 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM
K961541 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM
K961542 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
K961543 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM
K961546 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM
K961547 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM
K961548 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM
K961549 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM
K961551 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM
K961553 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM
K961554 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
K961556 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
K961558 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
K961559 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 17, 1996
DIAGNOSTIC ULTRASONIC TRANSDUCER
K941593 · IYO
Toshiba America Medical Systems, In.C
Radiology · 777d
Cleared May 17, 1996
UNILECT, MONITAB AND BIOTRACE-HR
K944497 · DRX
Msb , Ltd.
Cardiovascular · 612d
Cleared May 17, 1996
FOCUS MODEL 795 UNIT
K951951 · GZJ
Empi
Neurology · 387d
Cleared May 17, 1996
AXIOM-HVG
K955146 · IPF
Axiom Manufacturing
Physical Medicine · 186d
Cleared May 17, 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286 · CGA
Johnson & Johnson Clinical...
Chemistry · 183d
Cleared May 17, 1996
DUALSCREEN
K955291 · GZB
Medtronic Vascular
Neurology · 183d
Cleared May 17, 1996
SI2000 (SENSE-IT TRADEMARK) OR G2000
K955800 · DRX
Cmc Sense-It, Inc.
Cardiovascular · 147d
Cleared May 17, 1996
RECAP-1
K960641 · FMI
Medscience, Inc.
General Hospital · 93d