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
144265–144288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1986
GORDON DIAGNOSTIC SYSTEM MODEL I
K854903 · LQD
Clinical Diagnostics, Inc.
Neurology · 175d
Cleared Jun 02, 1986
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · DXN
Mennen Medical, Inc.
Cardiovascular · 174d
Cleared Jun 02, 1986
INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER
K860121 · DPT
NuMED, Inc.
Cardiovascular · 140d
Cleared Jun 02, 1986
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K860233 · HEM
General Electric Co.
Obstetrics & Gynecology · 131d
Cleared Jun 02, 1986
VOLUME CONTROL SET WITH EXTENSION
K860616 · FPA
Med Fusion Systems, Inc.
General Hospital · 103d
Cleared Jun 02, 1986
KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
K860956 · HQC
Medical Corp. of America
Ophthalmic · 81d
Cleared Jun 02, 1986
DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
K860957 · HQC
Medical Corp. of America
Ophthalmic · 81d
Cleared Jun 02, 1986
EASISTIM
K861091 · KOI
Promed Corp.
Anesthesiology · 70d
Cleared Jun 02, 1986
INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
K861226 · KRJ
Medical, Inc.
Cardiovascular · 62d
Cleared Jun 02, 1986
HIGH FLOW I.V. SET
K861275 · FPA
Migada, Ltd.
General Hospital · 56d
Cleared Jun 02, 1986
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
K861277 · DRY
Critichem, Inc.
Cardiovascular · 56d
Cleared Jun 02, 1986
ROHO HEEL PAD
K861327 · KIC
Roho, Inc.
Physical Medicine · 54d
Cleared Jun 02, 1986
BEHING-THE-EAR HEARING AID SERIES SP
K861597 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 02, 1986
CHURCHILL EXTENSION TUBE
K861626 · FPK
Churchill Corp.
General Hospital · 41d
Cleared Jun 02, 1986
STYLEKEEPER CONTACT LENS CARRYING CASE
K861643 · HPX
Allergan, Inc.
Ophthalmic · 33d
Cleared Jun 02, 1986
MONSANTO SANTOPRENE (PERITONE DEVICE)
K861683 · HIR
Peritone Research, Ltd.
Gastroenterology & Urology · 32d
Cleared Jun 02, 1986
RUBY & SAPPHIRE BLADE HOLDER
K861748 · HNN
Keeler Instruments, Inc.
Ophthalmic · 27d
Cleared Jun 02, 1986
BRUSHING
K861803
Beaute Naturelle International, Inc.
General & Plastic Surgery · 24d
Cleared Jun 02, 1986
LASER BRONCHOSCOPE SYSTEM
K861921 · LLO
Pilling Co.
Anesthesiology · 14d
Cleared Jun 02, 1986
LIDO BACK
K861986 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 11d
Cleared May 30, 1986
BIOCHEM 515 RESPIRATION MONITOR
K854333 · BZQ
Biochem International, Inc.
Anesthesiology · 214d
Cleared May 30, 1986
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
K860076 · DTW
Gambro, Inc.
Cardiovascular · 142d
Cleared May 30, 1986
FAST FLOW XX (AQUEOUS SOLUTION FILTER)
K860372 · FPB
Healthtek, Inc.
General Hospital · 116d
Cleared May 30, 1986
URENAMEL, POSTERIOR RESTORATIVE MATERIAL
K860487 · EBF
Cadco Dental Products, Inc.
Dental · 109d