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
98665–98688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1996
FRONTLINE CANNABIS
K954497 · LDJ
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Mar 06, 1996
FRONTLINE OPIATES
K954498 · DJG
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Mar 06, 1996
NIOMED BARRIER GOWNS
K954747 · FYC
Amerasia Corp.
General Hospital · 142d
Cleared Mar 06, 1996
THERATEST KIT (MODIFICATION)
K955481 · LJM
Theratest Laboratories, Inc.
Immunology · 112d
Cleared Mar 06, 1996
SAFELINE I.V. BAG ACCESS DEVICE
K955594 · LHI
Mcgaw, Inc.
General Hospital · 89d
Cleared Mar 06, 1996
SAFELINE MULTIDOSE VIAL ADAPTER
K955595 · LHI
Mcgaw, Inc.
General Hospital · 89d
Cleared Mar 06, 1996
NORTH STATE PLASTICS AEROSOL TEE
K955656 · BYX
North State Plastics, Inc.
Anesthesiology · 85d
Cleared Mar 06, 1996
DERMATOUCH LATEX GLOVES
K955670 · LYY
Concordia Research Lab
General Hospital · 89d
Cleared Mar 06, 1996
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
K955671 · OKS
G.W.B. Intl., Ltd.
Ophthalmic · 93d
Cleared Mar 06, 1996
SELFCARE EARLY PREGNANCY TEST
K955903 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 68d
Cleared Mar 06, 1996
STORZ S2050 SERIES BIPOLAR FORCEPS
K960009 · GEI
Storz Instrument Co.
General & Plastic Surgery · 64d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18...
K960123 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR...
K960124 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5...
K960125 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19...
K960126 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22...
K960127 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA H U ANTISERUM
K960132 · GRM
Sa Scientific, Inc.
Microbiology · 50d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9...
K960134 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA H M ANTISERUM
K960135 · GRM
Sa Scientific, Inc.
Microbiology · 50d
Cleared Mar 06, 1996
SAS SALMONELLA H P ANTISERUM
K960136 · GRM
Sa Scientific, Inc.
Microbiology · 50d
Cleared Mar 06, 1996
SAS SALMONELLA H Z10 ANTISERUM
K960137 · GRM
Sa Scientific, Inc.
Microbiology · 50d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9...
K960138 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7...
K960140 · GRM
Sa Scientific, Inc.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR...
K960142 · GRM
Sa Scientific, Inc.
Microbiology · 55d