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
172393–172416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1978
G WRAP
K780294 · FRG
Cel-Fibe
General Hospital · 35d
Cleared Mar 28, 1978
ADHESIVE, BRACKET AND CONDITIONER RESIN
K780334 · DYH
Rocky Mountain Orthodontics, Inc.
Dental · 28d
Cleared Mar 28, 1978
ECG MONITORING SYSTEM,
K780404 · DRT
Quinton, Inc.
Cardiovascular · 15d
Cleared Mar 27, 1978
IN VITRO THEOPHYLLINE RIA TEST
K772017 · KLS
Clinical Assays, Inc.
Immunology · 152d
Cleared Mar 27, 1978
CELL-CHEX
K780140 · JPK
Streck Laboratories, Inc.
Hematology · 60d
Cleared Mar 27, 1978
DIGAPHOT PHOTOTHERAPY METER MODEL PT 145
K780162 · FTA
Cavitron Corp.
General & Plastic Surgery · 55d
Cleared Mar 27, 1978
REDI-DISC HEMOGLOBIN GEL TUBE KIT
K780163 · JBD
Miles Laboratories, Inc.
Hematology · 55d
Cleared Mar 27, 1978
THROMBOPLASTIN DRIED
K780203 · GJS
Hyland Therapeutic Div., Travenol...
Hematology · 48d
Cleared Mar 27, 1978
SPECTROPHOTOMETER, FLUORESCENCE M.650-10
K780242 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 27, 1978
RECORDER, RE-100P HOT STYLUS STRIP CHART
K780245 · DSF
Waters Assoc., Inc.
Cardiovascular · 42d
Cleared Mar 27, 1978
CELL
K780305 · KJF
Dynatech Laboratories, Inc.
Pathology · 32d
Cleared Mar 27, 1978
I.V. START KIT
K780350 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 24d
Cleared Mar 27, 1978
DEN-Z-ORB
K780400 · KHR
Nice-Pak Products, Inc.
Dental · 14d
Cleared Mar 27, 1978
SUBCLAVIAN TRAY
K780419 · KGO
Concord Laboratories, Inc.
General Hospital · 13d
Cleared Mar 22, 1978
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · DXK
Hewlett-Packard Co.
Radiology · 22d
Cleared Mar 22, 1978
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
K780335 · DBA
Hyland Therapeutic Div., Travenol...
Immunology · 22d
Cleared Mar 22, 1978
MIF PROCEDURE KIT
K780346 · JTS
Marion Laboratories, Inc.
Immunology · 21d
Cleared Mar 22, 1978
T3 UPTAKE TEST
K780361 · KHQ
Monobind
Immunology · 16d
Cleared Mar 22, 1978
SPECTROFLUOROMETER SF-330
K780362 · KHO
Varian Assoc., Inc.
Toxicology · 16d
Cleared Mar 22, 1978
COUNTER, RADIOASSAY, AUTO., MICROMEDIC
K780383 · JJJ
Micromedic Systems
Immunology · 13d
Cleared Mar 22, 1978
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · JJE
Syva Co.
Immunology · 12d
Cleared Mar 22, 1978
SPECTROPHOTOMETER, ABSORPTION, ATOMIC
K780390 · JXR
Varian Assoc., Inc.
Toxicology · 12d
Cleared Mar 22, 1978
NASAL GASTRIC TUBE RETAINER
K780396 · FPK
Mor-Mac, Inc.
General Hospital · 9d
Cleared Mar 22, 1978
ORTHOPEDIC FORCEPS
K780397 · HTX
Orthopedic Equipment Co., Inc.
Orthopedic · 9d