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

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176,076 results
159073–159096 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1982
MAXICAMERA 400ZS
K828544
General Electric Co.
Radiology · 32d
Cleared Dec 20, 1982
MAXICAMERA 500A SMALL FIELD IMAGING SYSTEM
K828545
General Electric Co.
Radiology · 32d
Cleared Dec 19, 1982
STREPTACOCCUS CO-AGGLUTINATION KIT
K822799 · GTP
American Scientific Products
Microbiology · 94d
Cleared Dec 17, 1982
CURITY TRANSPARENT FILM DRESSING
K822424 · FRO
The Kendal Co.
General & Plastic Surgery · 127d
Cleared Dec 16, 1982
SURE & NATURAL MAXISHIELDS
K823239 · HHD
Personal Products Co.
Obstetrics & Gynecology · 45d
Cleared Dec 16, 1982
AUSTIN INHALATOR
K823246 · BYX
Ems Industries, Inc.
Anesthesiology · 45d
Cleared Dec 16, 1982
AMICON DIAFILTERS 20 & 30 HEMOFILTERS
K823288 · KDI
Amicon, Inc.
Gastroenterology & Urology · 42d
Cleared Dec 16, 1982
P-S MED. LUMBO PERITONEAL & VENTRICULO-
K823509 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 20d
Cleared Dec 16, 1982
RENAFLO II
K823546 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 16, 1982
MULTI-LUMEN INTRAVENOUS CATHETER
K823565 · FOZ
Mcpherson Enterprises, Inc.
General Hospital · 13d
Cleared Dec 15, 1982
AMES TDA GENTAMICIN TEST
K821669 · DJB
Miles Laboratories, Inc.
Chemistry · 191d
Cleared Dec 15, 1982
POWER SUTURE
K821702
Taylor H. Haynes, M.D.
General & Plastic Surgery · 190d
Cleared Dec 15, 1982
CORATOMIC #VX5-105 & VX5-205 PULSE GEN.
K822791 · DXY
Coratomic, Inc.
Cardiovascular · 91d
Cleared Dec 15, 1982
HTS *1
K822843 · DSK
Global Office Automation System, Inc.
Cardiovascular · 83d
Cleared Dec 15, 1982
DSL 1700
K822897 · JHW
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Dec 15, 1982
ELECTROCARDIOGRAPH INTERPRETER
K822968 · DSI
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Dec 15, 1982
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
K822978 · DSF
Siemens Corp.
Cardiovascular · 68d
Cleared Dec 15, 1982
BIO MAG FREE T4 RADIOIMMUNOASSAY KIT
K823005 · CEC
Bioclinical Group
Chemistry · 64d
Cleared Dec 15, 1982
MICRO TRAK CHLAMYDIA TRACHOMATIS CULT
K823010 · LJP
Syva Co.
Microbiology · 64d
Cleared Dec 15, 1982
SEA MED MODEL 880
K823048 · DTE
Seamed Corp.
Cardiovascular · 61d
Cleared Dec 15, 1982
INTRA CATH-DSA INTRAVENOUS CATH PLACE.
K823065 · DQO
Parke-Davis Co.
Cardiovascular · 58d
Cleared Dec 15, 1982
CARDIAC ELEVATOR
K823094 · DWS
Cardio Surgical Research, Inc.
Cardiovascular · 56d
Cleared Dec 15, 1982
SMEC BALLOON SYSTEM
K823177 · DSP
Smec, Inc.
Cardiovascular · 50d
Cleared Dec 15, 1982
FREE & TOTAL ESTRIOL KIT
K823202 · CGI
Diagnostic Products Corp.
Chemistry · 50d