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
143065–143088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1986
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · LGD
Organon Teknika Corp.
Microbiology · 94d
Cleared Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Sep 11, 1986
PULSE OXIMETER
K862426 · DPZ
Draeger Medical, Inc.
Anesthesiology · 77d
Cleared Sep 11, 1986
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642 · LQM
American Micro Scan
Microbiology · 62d
Cleared Sep 11, 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · DQO
Medtronic Vascular
Cardiovascular · 59d
Cleared Sep 11, 1986
ALBUMETER
K863050 · CIX
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
CHOLESTEROL-E (FREE)
K863064 · CHH
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
FAST MUCOPROTEINS
K863070 · JQN
J. D. Assoc.
Chemistry · 30d
Cleared Sep 11, 1986
CHOLINESTERASE
K863111 · DIH
J. D. Assoc.
Toxicology · 29d
Cleared Sep 11, 1986
HEALTHCHECK THERM-STRIP
K863181 · FQZ
Healthcheck Corp.
General Hospital · 23d
Cleared Sep 11, 1986
INORGANIC PHOSPHORUS PROCEDURE
K863264 · CEO
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
IRON PROCEDURE
K863266 · JIY
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
MAGNESIUM PROCEDURE
K863267 · CFA
Data Medical Associates, Inc.
Chemistry · 17d
Cleared Sep 11, 1986
INFUSE-A-PORT EXPLANT KIT
K863296 · LJT
Intermedics/Infusaid, Inc.
General Hospital · 17d
Cleared Sep 11, 1986
AEROSOL-T
K863318 · BZA
Southmedic, Inc.
Anesthesiology · 16d
Cleared Sep 11, 1986
CODE-A-WELL SERIES 1-600, 1-625
K863374 · JTC
Plastic Injectors, Inc.
Microbiology · 8d
Cleared Sep 09, 1986
MAXI-USE O2 DEVICE
K861325 · NFB
B & F Medical Products, Inc.
Anesthesiology · 153d
Cleared Sep 09, 1986
AGAR 9K TENS
K861894 · GZJ
Solcoor, Inc.
Neurology · 116d
Cleared Sep 09, 1986
UNI-TENS
K861895 · GZJ
Solcoor, Inc.
Neurology · 116d
Cleared Sep 09, 1986
UNI-TENS XL TENS
K861896 · GZJ
Solcoor, Inc.
Neurology · 116d
Cleared Sep 09, 1986
DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM
K862304 · FKQ
Cd Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Sep 09, 1986
HCI Y-CONNECTOR
K862484 · KOD
Hospital Concepts, Inc.
Gastroenterology & Urology · 71d
Cleared Sep 09, 1986
SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE
K862539 · FAD
Mentor Corp.
Gastroenterology & Urology · 69d
Cleared Sep 09, 1986
AMYLASE LTS
K862640 · CJA
Electro-Nucleonics Laboratories, Inc.
Chemistry · 61d