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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142513–142536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1986
HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES
K863720 · FIP
Water Pure, Inc.
Gastroenterology & Urology · 36d
Cleared Oct 29, 1986
NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT
K863723 · LJT
Norfolk Medical Products, Inc.
General Hospital · 36d
Cleared Oct 29, 1986
ENZYMUN-TEST(R) IGE
K863822 · DGC
Boehringer Mannheim Corp.
Immunology · 29d
Cleared Oct 29, 1986
IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC
K863844 · DHB
Immuno Nuclear Corp.
Immunology · 28d
Cleared Oct 29, 1986
LOMBARD DOWELL AGAR BASE
K864014 · KZI
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared Oct 29, 1986
TISSUE CULTURE FLASK
K864021 · KJA
Fenwal Laboratories
Pathology · 14d
Cleared Oct 29, 1986
MICROHEMATOCRIT CENTRIFUGE
K864039 · GKF
Plaza Medical, Inc.
Hematology · 13d
Cleared Oct 29, 1986
MCARTHUR MICROSCOPE, STANDARD METAL VERSION
K864049 · IBJ
Portable Medical Laboratories, Inc.
Pathology · 12d
Cleared Oct 29, 1986
ELASTIC STAIN
K864074 · IAC
Sigma Diagnostics, Inc.
Pathology · 9d
Cleared Oct 29, 1986
URIC ACID TEST
K864119 · KNK
U. S. Diagnostics, Inc.
Chemistry · 8d
Cleared Oct 28, 1986
MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND
K861044 · GEX
Sharplan Industries, Inc.
General & Plastic Surgery · 224d
Cleared Oct 28, 1986
MODEL 4-SC FOUR WAY STOPCOCK
K863165 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Oct 27, 1986
UNIVERSAL ACETABULAR COMPONENT
K861433 · JDI
Biomet, Inc.
Orthopedic · 194d
Cleared Oct 27, 1986
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
K862672 · BZT
Inmed Corp.
Anesthesiology · 105d
Cleared Oct 27, 1986
ADVANCED NUCLEAR COMPUTER
K862842 · LMB
Advanced Nuclear Imaging Corp.
Radiology · 90d
Cleared Oct 27, 1986
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 90d
Cleared Oct 27, 1986
SPIROLOOP-PULMONARY EXERCISE SYSTEM
K863087 · BTY
Pneumedics, Inc.
Anesthesiology · 76d
Cleared Oct 27, 1986
THERATRON-PHOENIX
K863180 · IWB
Aecl Medical
Radiology · 70d
Cleared Oct 27, 1986
ERS SYSTEM
K863286 · LMB
General Electric Co.
Radiology · 63d
Cleared Oct 27, 1986
KODAK EKTASCAN LASER PRINTER, MODEL 100
K863629 · LMC
Eastman Kodak Company
Radiology · 40d
Cleared Oct 27, 1986
COTTON ROLLS, NON-STERILE
K863764 · EFN
The Medical Group, Inc.
Dental · 32d
Cleared Oct 27, 1986
SALIVA EJECTORS
K863768 · DYN
The Medical Group, Inc.
Dental · 32d
Cleared Oct 27, 1986
VENTICIS II
K863778 · IYT
Cis-Us, Inc.
Radiology · 31d
Cleared Oct 27, 1986
IVORY PREMIUM RUBBER DAM
K863816 · EIE
Columbus Dental Mfg. Co.
Dental · 27d