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
154273–154296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1984
STREPTOCOCCUS GR. D
K840511 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS PNEUMONIAE CONTROL
K840512 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. B CONTROL
K840513 · GTY
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
NEISSERIA MENINGITIDIS CONTROL
K840514 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · DGC
Pharmacia, Inc.
Immunology · 44d
Cleared Mar 23, 1984
BLOOD CONCENTRATOR 140
K840543 · KDI
Gambro, Inc.
Gastroenterology & Urology · 44d
Cleared Mar 23, 1984
MOBILIZER
K840551 · ION
Lossing Orthopedic, Inc.
Physical Medicine · 44d
Cleared Mar 23, 1984
ELECTRODE PLACEMENT SLEEVE
K840591 · GXY
Bio-Stimu Trend Corp.
Neurology · 43d
Cleared Mar 23, 1984
ELECTRODE PLACEMENT LUMBAR SHORTS
K840592 · GXY
Bio-Stimu Trend Corp.
Neurology · 43d
Cleared Mar 23, 1984
QUINIDINE CALIBRATOR
K840597 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 43d
Cleared Mar 23, 1984
MASTERFOOT CAST HEEL
K840617 · LGF
Seton Products, Inc.
Orthopedic · 39d
Cleared Mar 23, 1984
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · LDR
Travenol Laboratories, S.A.
General Hospital · 37d
Cleared Mar 23, 1984
CRP SLIDE TEST KIT
K840699 · DCN
Difco Laboratories, Inc.
Immunology · 36d
Cleared Mar 23, 1984
POLYP-SAVER SLEVE
K840800 · OCZ
Jayco Pharmaceuticals
Gastroenterology & Urology · 29d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS SPS
K840804 · JTO
Difco Laboratories, Inc.
Microbiology · 28d
Cleared Mar 23, 1984
MICRODASE
K840819 · JTO
Remel Co.
Microbiology · 28d
Cleared Mar 23, 1984
TREONIC C30
K840823 · LDR
Vickers America Medical Corp.
General Hospital · 28d
Cleared Mar 23, 1984
OHIO 3000 INFANT WARMER SYSTEM
K840857 · FMT
Ohio Medical Products
General Hospital · 28d
Cleared Mar 23, 1984
OHIO 3300 INFANT WARMER SYSTEM
K840858 · FMT
Ohio Medical Products
General Hospital · 28d
Cleared Mar 23, 1984
STREP-A-CHEK TUBE
K840884 · JTO
E-Y Laboratories, Inc.
Microbiology · 25d
Cleared Mar 23, 1984
CLOSTRIDIUM DIFFICILE AGAR DEEP &
K840889 · JSI
Remel Co.
Microbiology · 25d
Cleared Mar 23, 1984
BUFFERED CYE AGAR DEEP W/SUPPLEMENTS
K840890 · JSJ
Remel Co.
Microbiology · 25d
Cleared Mar 23, 1984
PHOTO-THERAPY EYE PROTECTOR
K840894 · FOK
A & A Medical Supplies Co.
General Hospital · 25d
Cleared Mar 23, 1984
DIFFERENTIATION DISKS ALA
K840896 · JTO
Difco Laboratories, Inc.
Microbiology · 25d