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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
171481–171504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1978
CEA-IMMERSIBLE SEPARATOR
K781043 · JRL
Millipore Corp.
Immunology · 87d
Cleared Sep 15, 1978
STEMPLEX
K781167 · IPF
Rich-Mar Corp.
Physical Medicine · 64d
Cleared Sep 15, 1978
SIGNAL AVERAGER MODEL 4202
K781290 · GWK
Princeton Applied Research Corp.
Neurology · 50d
Cleared Sep 15, 1978
AC ADAPTER:MODELS 9525,9526,9527
K781535 · DXG
Edwards Laboratories
Cardiovascular · 9d
Cleared Sep 14, 1978
OXYGENATOR, BUBBLE TYPE
K780078 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 240d
Cleared Sep 14, 1978
PRESSURE INFUSION DEVICE
K781037 · KZD
Hinck Medical, Inc.
General Hospital · 87d
Cleared Sep 14, 1978
FORCEPS, ELECTROSURGICAL
K781109 · HIN
Kli
Obstetrics & Gynecology · 76d
Cleared Sep 14, 1978
DISSCAP
K781142 · FJI
Hospal Medical Corp.
Gastroenterology & Urology · 66d
Cleared Sep 14, 1978
HEMAC LASER HEMATOLOGY SYSTEM
K781146 · GKL
Ortho Instruments
Hematology · 66d
Cleared Sep 14, 1978
COMPUTER INTERFACE IL 814
K781173 · JQP
Instrumentation Laboratory CO
Chemistry · 63d
Cleared Sep 14, 1978
CLINAC 12/10
K781174 · IYE
Varian Assoc., Inc.
Radiology · 63d
Cleared Sep 14, 1978
CAMERAS, MULTI-IMAGE
K781214
Dunn Instruments, Inc.
Radiology · 59d
Cleared Sep 14, 1978
QUANTICEL-HRP
K781247 · JPK
Bhp Diagnostix, Inc.
Hematology · 55d
Cleared Sep 14, 1978
PREAMPLIFIER MODEL 113
K781289 · GWL
Princeton Applied Research Corp.
Neurology · 49d
Cleared Sep 14, 1978
HEMOGLOBINOMETER MODEL 720 B
K781361 · GKR
Innovative Medical Systems, Inc.
Hematology · 38d
Cleared Sep 14, 1978
STANDARDIZE TGCL & TGCH
K781376 · JTX
American Monitor Corp.
Chemistry · 36d
Cleared Sep 14, 1978
MODEL 5000, LIQUID CHROMATOGRAPHY
K781379 · KIE
Varian Assoc., Inc.
Toxicology · 34d
Cleared Sep 14, 1978
EBS 775 TONOMETER
K781386 · LCH
Equilibrated Bio Systems, Inc.
Chemistry · 34d
Cleared Sep 14, 1978
CREATININE REAGENT SET
K781396 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 35d
Cleared Sep 14, 1978
EM-V
K781397 · KSG
Biological Corp. of America
Hematology · 34d
Cleared Sep 14, 1978
ORTHO LOW IONIC SOLUTION
K781435 · KSG
Ortho Diagnostics, Inc.
Hematology · 29d
Cleared Sep 14, 1978
AUTO-FIELD II OPHTHALMIC FIELD SCANNER
K781462 · HPT
Cavitron Corp.
Ophthalmic · 20d
Cleared Sep 14, 1978
RIANEN ASSAY SYSTEM, 125I KIT
K781495 · DNL
New England Nuclear
Immunology · 15d
Cleared Sep 14, 1978
XIMATRON IV
K781496 · KPQ
Siemens Elema AB
Radiology · 15d