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
163681–163704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1981
SPOTAR
K810839 · ELW
Moyco Industries, Inc.
Chemistry · 33d
Cleared Apr 29, 1981
AMP PERITONEAL DIALYSIS PREP KIT
K810840 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 29, 1981
SILICONE ELASTOMER KIT
K810869 · EBI
Rapid Injection Systems Corp.
Dental · 29d
Cleared Apr 29, 1981
ARALUEN SKY GRAB BRIDLE
K810922 · FPP
Araluen, Inc.
General Hospital · 23d
Cleared Apr 29, 1981
VISIO-SEAL
K810950 · EBC
Espe Dental Products
Dental · 22d
Cleared Apr 29, 1981
ARROW VESSEL CATHETER. KIT W/20GA INDWEL
K810962 · DQY
Arrow Intl., Inc.
Cardiovascular · 21d
Cleared Apr 29, 1981
ANTI NDNA IMMUNOFLOURESCENT TEST SYS
K810981 · DHC
Immuno-Products Industries
Immunology · 16d
Cleared Apr 29, 1981
HEADSTRAP
K810991 · BTK
Respironics, Inc.
Anesthesiology · 16d
Cleared Apr 29, 1981
HELENA VMA-SMC COLUMN METHOD
K810992 · CDF
Helena Laboratories
Chemistry · 16d
Cleared Apr 29, 1981
GLUCOSCAN TEST STRIPS
K810993 · CGA
Lifescan, Inc.
Chemistry · 16d
Cleared Apr 29, 1981
AMES TDA TM PHENOBARBITAL TEST
K810994 · LET
Miles Laboratories, Inc.
Toxicology · 16d
Cleared Apr 29, 1981
ENTERNAL PUMP SET W/INTEGRAL CONTAINER
K810996 · KNT
Abbott Laboratories
Gastroenterology & Urology · 15d
Cleared Apr 29, 1981
ENDER PINS
K811002 · HSB
Richard'S Medical Equip., Inc.
Orthopedic · 16d
Cleared Apr 29, 1981
AMES TDA TM PRIMIDONE TEST
K811007 · LFT
Miles Laboratories, Inc.
Toxicology · 15d
Cleared Apr 29, 1981
LKB 4460 FLUORIMETER
K811019 · KHO
Lkb Instruments, Inc.
Chemistry · 14d
Cleared Apr 29, 1981
AMES TDA TM PHENYTOIN TEST
K811025 · LES
Miles Laboratories, Inc.
Toxicology · 13d
Cleared Apr 29, 1981
AMES TDA TM AMIKACIN TEST
K811026 · KLQ
Miles Laboratories, Inc.
Toxicology · 13d
Cleared Apr 29, 1981
PRO COMFORT TENNIS ELBOW SUPPORT/WRIST
K811035 · IQI
Scholl, Inc.
Physical Medicine · 13d
Cleared Apr 29, 1981
FILTER SAMPLER BLOOD SERUM FILTER
K811036 · JKA
Glasrock Plastics, Inc.
Chemistry · 13d
Cleared Apr 29, 1981
MANNITAL SALT AGAR
K811037 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
BAIRD-PARKER AGAR
K811038 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
MUELLER HINTON AGAR
K811049 · JTZ
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
TRYPTIC SOY BROTH
K811050 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
TRYPTIC SOY AGAR
K811051 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 13d