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

Filters: Cleared only ×
176,076 results
172369–172392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1978
INFANT ELECTROSURGICAL GROUNDING PAD
K780405 · JOS
New Dimensions IN Medicine, Inc.
General & Plastic Surgery · 23d
Cleared Apr 05, 1978
PACEMAKER, MODEL 252, C-MOS
K780437 · DXY
Intermedics, Inc.
Cardiovascular · 16d
Cleared Apr 05, 1978
PREBYPASS FILTER
K780485 · KRJ
Delta Medical Industries
Cardiovascular · 9d
Cleared Apr 05, 1978
CBR-DIGOXIN ANTISERUM
K780498 · DKA
Clinical Bioresearch
Toxicology · 8d
Cleared Apr 04, 1978
PREGNANCY TEST KIT, OVER-THE-COUNTER
K780321 · LCX
Intl. Diagnostic, Inc.
Chemistry · 39d
Cleared Apr 04, 1978
OXYGEN REGULATOR/FLOWMETER
K780359 · CAN
Erie Mfg., Co.
Anesthesiology · 29d
Cleared Apr 04, 1978
PINWHEEL
K780422 · GWY
Projects IN Health
Neurology · 18d
Cleared Apr 03, 1978
NEBULIZER, DISP, 2D0815
K780119 · CAF
Travenol Laboratories, S.A.
Anesthesiology · 70d
Cleared Apr 03, 1978
URINE SAMPLE KIT
K780336 · KDD
American Hospital Supply Corp.
General & Plastic Surgery · 34d
Cleared Mar 31, 1978
DIALYZING FLUIDE DELIVERY SYSTEM
K780081 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 74d
Cleared Mar 31, 1978
IMAGER, BODY SECTION, RADIONUCLIDE
K780395 · IYW
Union Carbide Corp.
Radiology · 18d
Cleared Mar 30, 1978
PLATELET ROTATOR
K780189 · KSQ
Travenol Laboratories, S.A.
Hematology · 52d
Cleared Mar 30, 1978
SOLUBLE COLLAGEN
K780285 · JOZ
General Diagnostics
Hematology · 37d
Cleared Mar 30, 1978
AUTO ISO-FILTER COLLECTION TUBE CAP
K780303 · GJE
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Mar 30, 1978
MANIFOLD KIT
K780364 · CAN
Spica, Inc.
Anesthesiology · 24d
Cleared Mar 30, 1978
OXYGEN/NITROUS OXIDE OUTLET
K780365 · CAM
Spica, Inc.
Anesthesiology · 24d
Cleared Mar 30, 1978
STIKSEP-T4 RIA KIT
K780423 · CDX
Nuclear Diagnostics, Inc.
Toxicology · 14d
Cleared Mar 30, 1978
ROCHE TSH RIA
K780428 · JLW
Hoffmann-La Roche, Inc.
Chemistry · 13d
Cleared Mar 30, 1978
TRACOR RA 410 AUDIOMETER
K780450 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 30, 1978
CLEARTONE MODEL-1 & 2 HEARING AIDS
K780459 · ESD
Cleartone Custom Hearing Instruments
Ear, Nose, Throat · 7d
Cleared Mar 30, 1978
AUDIOMETER CALIBRATOR MODEL RA 310
K780474 · EWA
Tracor Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Mar 28, 1978
I.V. START KIT
K780222 · FRO
Marion Laboratories, Inc.
General & Plastic Surgery · 47d
Cleared Mar 28, 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · KHQ
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Mar 28, 1978
HDL CHOLESTEROL METHOD
K780256 · JHO
Helena Laboratories
Chemistry · 43d