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
97417–97440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1996
SAS SALMONELLA H Z42 ANTISERUM
K961955 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H G,M,Q ANTISERMU
K961956 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z32 ANTISERUM
K961957 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4 COMPLEX ANTISERUM
K961958 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z24 ANTISERUM
K961960 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H F,G,T ANTISERUM
K961961 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
K961962 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
K961963 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
K961964 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM
K961966 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O POLY B ANTISERUM
K961967 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 17, 1996
IMMULITE CMV IGG
K950672 · LFZ
Diagnostic Products Corp.
Microbiology · 490d
Cleared Jun 17, 1996
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
K950838 · GNT
Zymetx, Inc.
Microbiology · 479d
Cleared Jun 17, 1996
VYGON PREMI-CATH - LONG TERM CATHETER
K954302 · LJS
Vygon Corp.
General Hospital · 278d
Cleared Jun 17, 1996
OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER
K955342 · DXN
Rashman Corp.
Cardiovascular · 210d
Cleared Jun 17, 1996
SERAQUEST TOXOPLASMA IGG
K960092 · LGD
Quest Intl., Inc.
Microbiology · 158d
Cleared Jun 17, 1996
SYSTEM, THERMAL REGULATING 74-DWJ
K960167 · DWJ
Augustine Medical, Inc.
Cardiovascular · 153d
Cleared Jun 17, 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · LIP
Pyramid Biological Corp.
Microbiology · 137d
Cleared Jun 17, 1996
IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW
K960899 · DZE
Imcor
Dental · 104d
Cleared Jun 17, 1996
STRESSWRITER EXERCISE TESTING SYSTEM
K961009 · DQK
Hewlett-Packard Co.
Cardiovascular · 97d
Cleared Jun 17, 1996
CT PROSPEED CT/I
K961055 · JAK
GE Medical Systems
Radiology · 91d
Cleared Jun 17, 1996
AUTOMATIC VISUAL FIELD PLOTTER AP-125
K961090 · HPT
Kowa Optimed, Inc.
Ophthalmic · 90d
Cleared Jun 17, 1996
COLISCREEN
K961191 · JTO
Hardy Diagnostics
Microbiology · 83d
Cleared Jun 17, 1996
FULL FRAME ZOOM SYSTEM
K961193 · JAA
Xre Corp.
Radiology · 88d