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
165697–165720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1980
CRUSADER HYPEREXTENSION BRACE
K803033 · IPY
Orthomedics
Physical Medicine · 21d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
PROFILE CARDIAC SET ASSAYED SERUM CONTR.
K803036 · DIF
General Diagnostics
Toxicology · 21d
Cleared Dec 22, 1980
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.
K803039 · DIF
General Diagnostics
Toxicology · 21d
Cleared Dec 22, 1980
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S
K803042 · DTB
Siemens Elema AB
Cardiovascular · 21d
Cleared Dec 22, 1980
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.
K803045 · DOG
American Dade
Toxicology · 21d
Cleared Dec 22, 1980
I-125 LABELED DIGOXIN
K803047 · LCS
Pcl-Ria, Inc.
Toxicology · 21d
Cleared Dec 22, 1980
VANCE UROSTOMY APPLIANCE
K803048 · EXB
Vance Products, Inc.
Gastroenterology & Urology · 21d
Cleared Dec 22, 1980
APEXLINE OF PULMONARY FUNCT. INSTRUM.
K803053 · BTY
Warren E. Collins, Inc.
Anesthesiology · 20d
Cleared Dec 22, 1980
SAF FIXATIVE
K803054 · IGB
Remel Co.
Microbiology · 20d
Cleared Dec 22, 1980
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K803059 · DTN
Extracorporeal Medical Specialities,...
Cardiovascular · 19d
Cleared Dec 22, 1980
FOLATE 125I RADIOIMMUNOASSAY
K803060 · CGN
Corning Medical & Scientific
Chemistry · 101d
Cleared Dec 22, 1980
STRAP EASE 400
K803063 · ILK
Independent Transfer Equipment Co.
Physical Medicine · 18d
Cleared Dec 22, 1980
SHELL KRATON THERMO-PLASTIC RUBBER COMP.
K803069 · BYP
Warren E. Collins, Inc.
Anesthesiology · 17d
Cleared Dec 22, 1980
DIGOXIN RIABEAD DIAGNOSTIC KIT
K803075 · DON
Abbott Laboratories
Toxicology · 17d
Cleared Dec 22, 1980
FOLEY CATHETER
K803079 · KOD
American Hospital Supply Corp.
Gastroenterology & Urology · 17d
Cleared Dec 22, 1980
ALL PUPOSE URETHRAL CATHETER
K803080 · KOD
American Hospital Supply Corp.
Gastroenterology & Urology · 17d
Cleared Dec 22, 1980
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082 · EXB
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 17d
Cleared Dec 22, 1980
MIC-BIOPLATE INOCULATOR
K803092 · JQW
Pasco Laboratories, Inc.
Microbiology · 14d
Cleared Dec 22, 1980
DIGOXIN & PHENYTOIN CONTROL SERA
K803097 · DIF
Amersham Corp.
Toxicology · 14d
Cleared Dec 22, 1980
PREBYPASS FILTER CAT.#K-5
K803101 · KRJ
Delta Medical Industries
Cardiovascular · 13d
Cleared Dec 22, 1980
ARTERIAL BUBBLE TRAP K-20
K803102 · KRL
Delta Medical Industries
Cardiovascular · 13d
Cleared Dec 22, 1980
AMES TDA AMIKACIN CONTROL SERUM
K803107 · LAS
Miles Laboratories, Inc.
Chemistry · 12d