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
142561–142584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1986
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K863680 · DZE
Interpore Intl.
Dental · 35d
Cleared Oct 24, 1986
ANTI-DNA MICROASSAY
K863717 · DHN
Diamedix Corp.
Immunology · 31d
Cleared Oct 24, 1986
BESCURE
K863739 · KNX
U-T, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 24, 1986
VALTRAC (BAR) REMOVER DEVICE
K863752 · EMF
Davis & Geck, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
2X2 SPONGES, NON-STERILE
K863760 · EFQ
The Medical Group, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
2X2 SPONGES, NON-STERILE, COTTON FILLED
K863761 · EFQ
The Medical Group, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
CONTOUR CUP MASKS
K863774
The Medical Group, Inc.
General & Plastic Surgery · 29d
Cleared Oct 24, 1986
B-WRAP
K863777
Bdf Plaza
General & Plastic Surgery · 28d
Cleared Oct 24, 1986
SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
K863824 · FKH
D.R.G. Scientific Industries
Gastroenterology & Urology · 24d
Cleared Oct 24, 1986
DEXTRA DISPOSABLE BLADES
K863867 · GES
Storz Instrument Co.
General & Plastic Surgery · 21d
Cleared Oct 24, 1986
GAUZE, NONABSORBABLE, NON-MEDICATED (INTERNAL)
K863870 · EFQ
Med-Tex, Inc.
General & Plastic Surgery · 21d
Cleared Oct 24, 1986
OPERATING ROOM TOWELS - STERILE/NON STERILE
K863871 · KKX
Med-Tex, Inc.
General Hospital · 21d
Cleared Oct 24, 1986
SABLE BLADES
K863885 · GES
Sable Industries
General & Plastic Surgery · 18d
Cleared Oct 24, 1986
GAUZE, ABSORBENT, STERILE, COMPRESSED
K863932 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 16d
Cleared Oct 24, 1986
POREX(TM) EAR PROSTHESIS
K863939 · FZD
Porex Medical
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
POREX(TM) PROSTHESIS, CHIN, INTERNAL
K863941 · FWP
Porex Medical
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
POREX(TM) NOSE PROSTHESIS
K863942 · FZE
Porex Medical
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL
K863950 · GDX
Precision Surgical Industries, Inc.
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
K863951 · GDZ
Precision Surgical Industries, Inc.
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU
K863957 · FGE
Cathaid, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 24, 1986
LIMB-GUARD
K863964
Sparco, Inc.
General & Plastic Surgery · 14d
Cleared Oct 24, 1986
OCEAN SCIENTIFIC VACUTEST
K863976 · JKA
Ocean Scientific, Inc.
Chemistry · 10d
Cleared Oct 24, 1986
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
K863982 · JCY
Vas-Cath of Canada , Ltd.
General & Plastic Surgery · 10d
Cleared Oct 24, 1986
ACCLAIM* BRACKET ADHESIVE
K864008 · DYH
Johnson & Johnson Professionals, Inc.
Dental · 9d