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
164521–164544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1981
MK6 ERA SYSTEM
K810473 · GWJ
Amplaid USA, Inc.
Neurology · 65d
Cleared Apr 29, 1981
SOMATOSENSORY STIMULATOR
K810482 · GWF
Amplaid USA, Inc.
Neurology · 65d
Cleared Apr 29, 1981
PLASTICEPH
K810538 · EAG
Morningstar Dental Co.
Radiology · 62d
Cleared Apr 29, 1981
AUDIOMETER
K810583 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 57d
Cleared Apr 29, 1981
HEMOPHRON
K810612 · FKQ
Renal Devices, Inc.
Gastroenterology & Urology · 54d
Cleared Apr 29, 1981
NEOCARE TEMPERATURE MONITOR
K810792 · FMZ
Vickers America Medical Corp.
General Hospital · 37d
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