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
164857–164880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 22, 1980
HYPERALIMENTATION DRESSING CHANGE TRAY
K803114 · FRO
American Medical Disposable, Inc.
General & Plastic Surgery · 12d
Cleared Dec 22, 1980
SIMPLE DRESSING TRAY #82028
K803118 · KDD
American Medical Disposable, Inc.
General & Plastic Surgery · 12d
Cleared Dec 20, 1980
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · CBK
Draeger Medical, Inc.
Anesthesiology · 103d
Cleared Dec 19, 1980
ACCU-COUNTER SURGICAL SPONGE COUNTING SY
K802868
Surgical Systems, Inc.
General & Plastic Surgery · 35d
Cleared Dec 19, 1980
SHEA LOCKING BAIL PROSTHESIS
K802873 · ETB
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 35d
Cleared Dec 19, 1980
AMIKACIN RIA KIT
K802877 · KLQ
Antibodies, Inc.
Chemistry · 32d