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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161137–161160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1982
DISPOS. MONITORING SYS/LI ET AL
K820201 · DRS
Linton Biomed Corp.
Cardiovascular · 17d
Cleared Feb 12, 1982
CONTINUOUS FLUSH DEVICE/FDI
K820202 · DRS
Linton Biomed Corp.
Cardiovascular · 17d
Cleared Feb 12, 1982
ZYME B
K820209 · JTO
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
IND
K820210 · JTO
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
NINHYDRIN
K820211 · JTO
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
OXI
K820212 · JTO
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
SALINE SOLUTION
K820213 · JTO
Dms Laboratories
Microbiology · 17d
Cleared Feb 12, 1982
LKB-WALLACE 1251 LUMINOMETER
K820217 · JJQ
Lkb Instruments, Inc.
Hematology · 17d
Cleared Feb 12, 1982
SWAN-GANZ VIP-CATHETER
K820222 · DYG
American Edwards Laboratories
Cardiovascular · 16d
Cleared Feb 12, 1982
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229 · DYG
Norton Performance Plastics Corp.
Cardiovascular · 16d
Cleared Feb 12, 1982
ULTRAZYME PLUS GAMMA GT(65055-65056)
K820233 · JQB
Harleco
Chemistry · 15d
Cleared Feb 12, 1982
TPTZ CHLORIDE
K820235 · CHJ
American Monitor Corp.
Chemistry · 15d
Cleared Feb 12, 1982
WAKO CALCIUM C TEST
K820241 · CIC
Wako Chemicals USA, Inc.
Chemistry · 14d
Cleared Feb 12, 1982
ANA TEST (MOUSE LIVER SUBSTRATE)
K820265 · DHN
Meloy Laboratories, Inc.
Immunology · 10d
Cleared Feb 12, 1982
ARTHROSCOPIC HARPOON
K820275 · HRX
The Anspach Effort, Inc.
Orthopedic · 10d
Cleared Feb 12, 1982
TELESCAN T-30
K820276 · DXH
Telescan Medical Systems
Cardiovascular · 10d
Cleared Feb 12, 1982
ACE BRAND INSTANT COLD PACK
K820282 · IMD
Bd Becton Dickinson Vacutainer...
Physical Medicine · 10d
Cleared Feb 10, 1982
STERILE DISPOSABLE SURGICAL GLOVES
K812421 · KGO
Intermarket Latex, Inc.
General Hospital · 170d
Cleared Feb 10, 1982
DAKO PAP KIT K505
K812484 · DEW
Dako Corp.
Pathology · 163d
Cleared Feb 10, 1982
DAKO PAP KIT K504
K812485 · DFH
Dako Corp.
Pathology · 163d
Cleared Feb 10, 1982
10D (TENS DEVICE)
K813283 · GZJ
Staodynamics, Inc.
Neurology · 79d
Cleared Feb 10, 1982
KEY MED FOREIGN BODY REMOVAL TUBE
K813325 · FED
Keymed, Inc.
Gastroenterology & Urology · 78d
Cleared Feb 10, 1982
DEVICE FOR REPOSITIONING A BET PATIENT
K813356 · FNJ
Ali-Oop Co., Inc.
General Hospital · 75d
Cleared Feb 10, 1982
FREEZE DRIED FICIN
K813404 · KSK
Biological Corp. of America
Immunology · 65d