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
144865–144888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1986
ENZYMATIC URIC ACID REAGENT
K860732 · KNK
Trace Scientific , Ltd.
Chemistry · 49d
Cleared Apr 16, 1986
NON-CIRCULAR ORBITING OPTION
K861252 · KPS
Siemens Gammasonics, Inc.
Radiology · 13d
Cleared Apr 15, 1986
LIFE PAC
K854807 · KZD
Lifemed Technologies, Inc.
General Hospital · 133d
Cleared Apr 15, 1986
FC-1000 FLUOROSCOPIC IMAGING COMPUTER
K854810 · LLZ
Inficon Leybold-Heraeus, Inc.
Radiology · 133d
Cleared Apr 15, 1986
CD-200 CARDIAC MONITOR
K860175 · DPS
Cardio Display Corp.
Cardiovascular · 88d
Cleared Apr 15, 1986
MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC
K860278 · GEX
Britt Corp., Inc.
General & Plastic Surgery · 78d
Cleared Apr 15, 1986
PHOTRON VISUAL FIELD ANALYZER
K860642 · HOM
Biosan Laboratories, Inc.
Ophthalmic · 54d
Cleared Apr 15, 1986
BEHRING NEPHELOMETER SYSTEM
K860894 · CFN
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Apr 15, 1986
STORZ/MAZZACCO LENS FORCEP
K860915 · HNR
Storz Instrument Co.
Ophthalmic · 35d
Cleared Apr 15, 1986
LM-850 AUTOMATIC LENSMETER
K861064 · HLM
Nidek, Inc.
Ophthalmic · 26d
Cleared Apr 15, 1986
SUEL BLOOD LANCET
K861151 · FMK
Exel Intl.
General & Plastic Surgery · 20d
Cleared Apr 15, 1986
ALBA HEALTH CARE PLAIN PACKING STRIP
K861154 · EFQ
Alba Health Care
General & Plastic Surgery · 18d
Cleared Apr 15, 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · KTT
Depuy, Inc.
Orthopedic · 15d
Cleared Apr 15, 1986
ACCUPAC CUSTOM SKIN SCRUB KIT
K861219
Geneva Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared Apr 15, 1986
JOINT MEASUREMENT INDICATOR
K861264 · JDL
Devcom, Inc.
Orthopedic · 11d
Cleared Apr 14, 1986
BOMED-CDM
K853706 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 222d
Cleared Apr 14, 1986
EARLENS
K854311 · ESD
Sound Acoustic Systems, Ltd.
Ear, Nose, Throat · 171d
Cleared Apr 14, 1986
TIGER'S DIGITAL THERMOMETER
K854349 · FLL
Tiger Electronics, Inc.
General Hospital · 167d
Cleared Apr 14, 1986
ULTRASONIC COUPLANT GEL
K854996 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 123d
Cleared Apr 14, 1986
MX4040 INTRAUTERINE PRESSURE MONITORING KIT
K860101 · KXO
Medex, Inc.
Obstetrics & Gynecology · 94d
Cleared Apr 14, 1986
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)
K860747 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 46d
Cleared Apr 14, 1986
DISPETTE II
K860899 · JPH
Ulster Scientific, Inc.
Hematology · 35d
Cleared Apr 14, 1986
RESIDENTIAL TANNING UNIT
K861076 · FTC
Sunmaker, Inc.
General & Plastic Surgery · 24d
Cleared Apr 14, 1986
ZIMMER VACUUM MIXING SYSTEM
K861086 · JDZ
Zimmer, Inc.
Orthopedic · 24d