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
142489–142512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1986
COLTENE JET-MIXER
K863998 · EID
Coltene, Inc.
Dental · 16d
Cleared Oct 30, 1986
SLOTTED PUNCH
K864017
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
HACKSAW
K864018
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
NEEDLE NOSE PLIERS
K864019 · HTC
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
ICE PICK
K864020
Med-Tool, Inc.
General & Plastic Surgery · 15d
Cleared Oct 30, 1986
NONCONDUCTIVE SHOE COVER
K864026 · FXP
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Oct 30, 1986
LATEX SURGICAL GLOVES
K864064 · KGO
Futuremed Div. of Future Impex Corp.
General Hospital · 10d
Cleared Oct 30, 1986
COOK (R) VEIN GRAFT RING MARKERS
K864101 · KPK
Cook, Inc.
Cardiovascular · 9d
Cleared Oct 30, 1986
STERILE FIELD #605 FENESTRATED STERILE FIELD #606
K864111 · KKX
Graham Medical Products
General Hospital · 9d
Cleared Oct 29, 1986
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634 · LIQ
Wellcome Diagnostics
Microbiology · 183d
Cleared Oct 29, 1986
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
K861882 · MSJ
Orion Corp.
Immunology · 167d
Cleared Oct 29, 1986
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
K861883 · MSJ
Orion Corp.
Immunology · 167d
Cleared Oct 29, 1986
MEVATRON KD-2
K862339 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 131d
Cleared Oct 29, 1986
STARCHILD SLEEPDRY
K862757 · KPN
Starchild, Inc.
Gastroenterology & Urology · 99d
Cleared Oct 29, 1986
CANCELLOUS SCREW
K862990 · HRX
Orthopedic Systems, Inc.
Orthopedic · 82d
Cleared Oct 29, 1986
LIGAMENT WASHER
K862991 · HRX
Orthopedic Systems, Inc.
Orthopedic · 82d
Cleared Oct 29, 1986
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K863224 · JPK
Fisher Scientific Co., LLC
Hematology · 69d
Cleared Oct 29, 1986
SENGEWALD CATALOG NUMBER 55 66 01
K863323 · KKX
Sengewald/USA, Inc.
General Hospital · 63d
Cleared Oct 29, 1986
THE FIAX 5000 FLUOROMETER
K863434 · JZT
Whittaker Bioproducts, Inc.
Immunology · 55d
Cleared Oct 29, 1986
BARD BALLOON DILATATION SYSTEM
K863437 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 29, 1986
SERACON CT REFERENCE
K863648 · JJY
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 36d