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
172345–172368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1978
VIVONEX DELIVERY SYSTEM
K780415 · FPD
Norwich Pharmacal Co.
Gastroenterology & Urology · 27d
Cleared Apr 10, 1978
BURN DRESSING PAD
K780418 · FPY
The Owenby Co.
General & Plastic Surgery · 27d
Cleared Apr 10, 1978
CHAMBER, AEROBIC
K780440 · JTW
Marion Laboratories, Inc.
Microbiology · 21d
Cleared Apr 10, 1978
PANORAMIC X-RAY, DENTAL
K780469 · EHD
Den-Tal-Ez Mfg Co., Inc.
Radiology · 19d
Cleared Apr 10, 1978
I.V. LEVER CLAMP
K780481 · FPA
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Apr 10, 1978
NEIA-FERRITIN ENZYMEIMMUNOASSAY
K780490 · DBF
New England Immunology Assoc.
Immunology · 14d
Cleared Apr 10, 1978
ELECATH PLASTIC JACKETED GUIDEWIRE
K780493 · DQX
Electro-Catheter Corp.
Cardiovascular · 14d
Cleared Apr 10, 1978
AMIKACIN
K780494 · KLQ
Diagnostic Products Corp.
Toxicology · 14d
Cleared Apr 10, 1978
DIGITOXIN
K780495 · DJK
Diagnostic Products Corp.
Toxicology · 14d
Cleared Apr 10, 1978
NOVA AIR FLOATATION SYSTEM
K780502 · FNM
Nova Health Systems, Inc.
General Hospital · 12d
Cleared Apr 10, 1978
INFUSION PUMP
K780503 · FRN
Air-Shields, Inc.
General Hospital · 12d
Cleared Apr 10, 1978
BEHIND-THE-EAR MASKING AMPLIFIER,735S
K780546 · KLW
Danavox, Inc.
Ear, Nose, Throat · 5d
Cleared Apr 10, 1978
STERILE ORTHOPEDIC STOCKINETTE
K780547 · ILG
Alba-Waldensian, Inc.
Physical Medicine · 5d
Cleared Apr 07, 1978
SOLID-OX EMERGENCY OXYGEN
K780366 · CAW
Cleanweld Products, Inc.
Anesthesiology · 32d
Cleared Apr 06, 1978
NEPHELOMETER
K780251 · JQX
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Apr 06, 1978
CHOLESTEROL RAPID SLAT KIT HDL
K780331 · CHH
Pierce Chemical Co.
Chemistry · 37d
Cleared Apr 05, 1978
LEAD HAND
K772387 · KKX
Edward Weck, Inc.
General Hospital · 99d
Cleared Apr 05, 1978
ATOMIZER, FURNACE, GRAPHITE
K780129 · JXR
The Perkin-Elmer Corp.
Toxicology · 71d
Cleared Apr 05, 1978
DIRECT UREA NITROGEN TEST
K780262 · CDW
Hycel, Inc.
Chemistry · 47d
Cleared Apr 05, 1978
CALIBRATORS, CARBON DIOXIDE
K780295 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 43d
Cleared Apr 05, 1978
DIAGNOSTIC KIT, CPK
K780311 · CGS
Sclavo, Inc.
Chemistry · 40d
Cleared Apr 05, 1978
AUTONOM
K780312 · KNM
Autonomic Equipment Supply Co,
Physical Medicine · 49d
Cleared Apr 05, 1978
DRI-LYTE
K780353 · KPO
Mallinckrodt Critical Care
Gastroenterology & Urology · 33d
Cleared Apr 05, 1978
TITANIUM MULLER TOTAL HIP
K780357 · JDG
Biomet, Inc.
Orthopedic · 30d