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
147481–147504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464 · CFR
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Sep 04, 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · CEM
American Dade
Chemistry · 12d
Cleared Sep 03, 1985
ECLIPSE SELF ADHERING ELECTRODE
K850646 · GXY
Todd Medical, Inc.
Neurology · 196d
Cleared Sep 03, 1985
INTRAORAL DENTAL X-RAY SYSTEM 70-X
K851095 · EHD
Trophy Radiologie
Radiology · 168d
Cleared Sep 03, 1985
OXYGEN DELIVERY MEASURING DEVICE
K851288 · CAX
Bar-Dix, Inc.
Anesthesiology · 155d
Cleared Sep 03, 1985
HEATED RESPIRATORY HUMIDIFIER
K851879 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 127d
Cleared Sep 03, 1985
ESOPHAGEAL STETHOSCOPE WITH ELECTRICAL CONDUCTORS
K852228 · BZT
Sensortek, Inc.
Anesthesiology · 104d
Cleared Sep 03, 1985
POSICAM TM(MODEL 3.2,4.3,6.5)
K852239 · KPS
Position Corp.
Radiology · 103d
Cleared Sep 03, 1985
RHYNOSTAT H-12 & V-22
K852349 · KPR
Remesta Medical Corp.
Radiology · 95d
Cleared Sep 03, 1985
SINGLE USE ARTHROSCOPY ELECTRODE
K852355 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 92d
Cleared Sep 03, 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · JPK
Abbott Diagnostics
Hematology · 91d
Cleared Sep 03, 1985
CELL SAVER SUCTION SYSTEM
K852425 · CAC
Haemonetics Corp.
Anesthesiology · 88d
Cleared Sep 03, 1985
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611 · CDM
Miles Laboratories, Inc.
Chemistry · 76d
Cleared Sep 03, 1985
#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG
K853065 · CAI
Sigma Medical, Inc.
Anesthesiology · 46d
Cleared Sep 03, 1985
RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR
K853083 · BYJ
Home Medical Supply, Inc.
Anesthesiology · 42d
Cleared Sep 03, 1985
PAX METER
K853085 · JAX
Peace Medical, Inc.
Anesthesiology · 42d
Cleared Sep 03, 1985
IMMUNO-IM
K853105 · KTN
Immunostics Co., Inc.
Immunology · 42d
Cleared Sep 03, 1985
DIMENSION TOTAL HIP PROSTHESIS
K853333 · KDI
Kirschner Medical Corp.
Gastroenterology & Urology · 26d
Cleared Sep 03, 1985
SERA-210 ELECTROLYTE ANALYZER
K853356 · CEM
Horiba Instruments, Inc.
Chemistry · 22d
Cleared Sep 03, 1985
N20 TEST
K853360 · CBR
Erich Jaeger, Inc.
Anesthesiology · 22d
Cleared Sep 03, 1985
H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
K853362 · JXG
Holter-Hausner Intl.
Neurology · 22d
Cleared Sep 03, 1985
H-H CRUCIFORM-SLIT VALVE
K853363 · JXG
Holter-Hausner Intl.
Neurology · 22d
Cleared Sep 03, 1985
PLATE INCUBATOR
K853379 · JTQ
Scientific Sales Intl., Inc.
Microbiology · 22d
Cleared Aug 30, 1985
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368 · JIN
Sigma Chemical Co.
Chemistry · 211d