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
145345–145368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1986
RPMI 1640 HEPES
K860786 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
DULBECCO'S MEM
K860787 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
HAM'S F-12 W/GLUTAMINE & NAHCO3
K860788 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
SPOTTEST CALCOFLUOR WHITE REAGENT
K860795 · LED
Difco Laboratories, Inc.
Pathology · 8d
Cleared Mar 11, 1986
PATIENT MONITOR PB240
K853318 · DRT
Puritan Bennett Corp.
Cardiovascular · 216d
Cleared Mar 11, 1986
HARD CONTACT LENS CLEANING & SOAKING SOLUTION
K853808 · HPX
Maurry Biological Co.
Ophthalmic · 181d
Cleared Mar 11, 1986
DAILY HARD CONTACT LENS CLEANER
K853809 · HPX
Maurry Biological Co.
Ophthalmic · 181d
Cleared Mar 11, 1986
RESPIRATORY RESUSCITATION DEVICE
K854029 · CAE
John H. Harrison
Anesthesiology · 161d
Cleared Mar 11, 1986
SIRECUST 341 AND 341R
K854881 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 95d
Cleared Mar 11, 1986
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917 · DTB
Intermedics, Inc.
Cardiovascular · 92d
Cleared Mar 11, 1986
MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD
K854918 · DTB
Intermedics, Inc.
Cardiovascular · 92d
Cleared Mar 11, 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · GTZ
Oxoid U.S.A., Inc.
Microbiology · 91d
Cleared Mar 11, 1986
AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
K855034 · LIJ
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 84d
Cleared Mar 11, 1986
ANGIOMED URETER DIATION SETS
K855076 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 82d
Cleared Mar 11, 1986
CURITY FIBEROPTIC INTUBATING AIRWAY
K855137 · CAE
The Kendal Co.
Anesthesiology · 78d
Cleared Mar 11, 1986
ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY
K855142 · FGE
Angiomed U.S., Inc.
Gastroenterology & Urology · 75d
Cleared Mar 11, 1986
ANGIOMED EXCHANGE DRAINAGE CATHETER SETS
K855143 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 75d
Cleared Mar 11, 1986
MENTOR SINGLE COIL URINARY DIVERSION STENT SET
K860055 · FAD
Mentor Corp.
Gastroenterology & Urology · 64d
Cleared Mar 11, 1986
NEISSERIASTAT
K860156 · JTO
Richardson Scientific, Inc.
Microbiology · 54d
Cleared Mar 11, 1986
THE HOLTER REPORTER (TM)
K860249 · DPS
Applied Cardiac Systems
Cardiovascular · 46d
Cleared Mar 11, 1986
API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC
K860369 · JWY
Analytical Products, Inc.
Microbiology · 36d
Cleared Mar 11, 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · KOD
The Kendal Co.
Gastroenterology & Urology · 29d
Cleared Mar 11, 1986
MENTOR CORPORAL DILATORS
K860517 · FAE
Mentor Corp.
Gastroenterology & Urology · 28d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS RIFAMPIN 15 MCG
K860560 · JTO
Difco Laboratories, Inc.
Microbiology · 25d