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
139465–139488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1987
FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE
K872597 · DWO
Dianon Systems, Inc.
General & Plastic Surgery · 26d
Cleared Jul 28, 1987
OPSITE SPECIALITY DRAPES
K872757 · KKX
Smith & Nephew, Inc.
General Hospital · 15d
Cleared Jul 27, 1987
DIABETES RISK DETECTOR
K864544 · JIL
Pearce Clinical Laboratories, Inc.
Chemistry · 250d
Cleared Jul 27, 1987
OVUQUICK SELF-TEST (OVUQUICK
K871726 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 83d
Cleared Jul 27, 1987
MODIFIED LIFECARE(R) 4100 PCA INFUSER
K871728 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Jul 27, 1987
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · HQC
CooperVision, Inc.
Ophthalmic · 75d
Cleared Jul 27, 1987
IV ADMINISTRATION SET
K871908 · BRZ
Travenol Laboratories, S.A.
General Hospital · 73d
Cleared Jul 27, 1987
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
K872320 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
K872322 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Jul 27, 1987
FRIGITRONICS ACC-1000 CAPSULE CUTTER
K872362 · HQC
Frigitronics of Connecticut, Inc.
Ophthalmic · 39d
Cleared Jul 27, 1987
T.E.N.S. DEVICE MODEL SPL 2000S
K872399 · GZJ
Spartan Laboratories, Inc.
Neurology · 35d
Cleared Jul 27, 1987
FH LEN
K872503 · HQY
Fu Heng First Industrial Co., Ltd.
Ophthalmic · 33d
Cleared Jul 27, 1987
MELANITE I
K872506 · HQG
Aura Lens Products
Ophthalmic · 33d
Cleared Jul 27, 1987
FORTEC MI-306, MI-327 DIGITAL THERMOMETER
K872584 · FLL
Nam Tai , Ltd.
General Hospital · 26d
Cleared Jul 27, 1987
HAND/FOOT UVA/UVB 624-224
K872649 · FTC
National Biological Corp.
General & Plastic Surgery · 20d
Cleared Jul 27, 1987
PANOSOL 2000 624-604
K872650 · FTC
National Biological Corp.
General & Plastic Surgery · 20d
Cleared Jul 27, 1987
PANOSOL 2000 624-414
K872651 · FTC
National Biological Corp.
General & Plastic Surgery · 20d
Cleared Jul 27, 1987
TAPELESS EYE SHIELD
K872659 · HOY
Precision Therapeutics, Inc.
Ophthalmic · 20d
Cleared Jul 27, 1987
PANOSOL 2000 624-616
K872706 · FTC
National Biological Corp.
General & Plastic Surgery · 20d
Cleared Jul 27, 1987
PANOSOL 2000 624-404
K872707 · FTC
National Biological Corp.
General & Plastic Surgery · 20d
Cleared Jul 27, 1987
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared Jul 27, 1987
INFUSION PUMP ENCLOSURE
K872821 · FRN
Pharmacia Deltec, Inc.
General Hospital · 10d
Cleared Jul 24, 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · FRO
Beiersdorf, Inc.
General & Plastic Surgery · 220d
Cleared Jul 24, 1987
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
K871400 · DXK
Ge Medical Systems Information...
Cardiovascular · 107d