Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
161977–162000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1982
BARD CARDIOPULMONARY MONITORING LINES
K820186 · DRS
C.R. Bard, Inc.
Cardiovascular · 21d
Cleared Feb 12, 1982
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
K820187 · LES
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
CARBAMAZEPINE ASSAY
K820189 · KLT
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
CALIBRATOR SET
K820190 · DKB
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
CONTROL SET
K820191 · DIF
Syva Co.
Toxicology · 18d
Cleared Feb 12, 1982
ELECTROSURGICAL DISP. DISPERSIVE PAD
K820196 · KNS
Promedicon, Inc.
Gastroenterology & Urology · 18d
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