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
171265–171288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1978
CHOLESTEROL DET. IN SERUM
K781611 · CGO
Fisher Scientific Co., LLC
Chemistry · 35d
Cleared Oct 24, 1978
SHILEY CRICOTHYROTOMY TUBE
K781639 · EQN
Shiley, Inc.
Ear, Nose, Throat · 33d
Cleared Oct 24, 1978
ASSAY SYSTEM, GAMMAFLO, AUTOMATED
K781659
E. R. Squibb & Sons, Inc.
Toxicology · 26d
Cleared Oct 24, 1978
RIA, DIGOXIN
K781660 · DON
E. R. Squibb & Sons, Inc.
Toxicology · 26d
Cleared Oct 24, 1978
STERILIZER, EAGLE 2000
K781684 · FLE
American Sterilizer Co.
General Hospital · 22d
Cleared Oct 24, 1978
EAGLE PAC/VISIBLE SEAL
K781699 · KCT
American Sterilizer Co.
General Hospital · 13d
Cleared Oct 24, 1978
MOBIL XR
K781705 · IZL
Siemens Corp.
Radiology · 14d
Cleared Oct 24, 1978
SCANNER, LINEAR
K781709 · IYO
Philips Medical Systems (Cleveland),...
Radiology · 14d
Cleared Oct 24, 1978
BUFFER, COLLAGEN REAGENT AND DILUENT
K781710 · JBX
Diagnostica, Inc.
Hematology · 19d
Cleared Oct 24, 1978
EVALUSKOP
K781711 · JAA
Siemens Corp.
Radiology · 19d
Cleared Oct 24, 1978
BLADE, 20 ANGLE/MICRO BLADE HOLDER
K781716 · GES
Edward Weck, Inc.
General & Plastic Surgery · 19d
Cleared Oct 24, 1978
TRACHEOTOMY TUBES
K781729 · BTO
Tracoe Medical GmbH
Anesthesiology · 14d
Cleared Oct 24, 1978
SODIUM CHLORIDE, 0.85%
K781734
Bioscientific
Chemistry · 12d
Cleared Oct 24, 1978
ENDOPROSTHESIS SYSTEM, VARIO-HEAD
K781735 · KWY
Waldemar Link GmbH & Co. KG
Orthopedic · 12d
Cleared Oct 23, 1978
RESPIRATORY EXERCISOR, VOLUME PULSE
K781669 · BWF
Bd Becton Dickinson Vacutainer...
Anesthesiology · 20d
Cleared Oct 18, 1978
PACEMAKER, MODEL 251-01
K781568
Intermedics, Inc.
Cardiovascular · 34d
Cleared Oct 17, 1978
IDENTI-LOOPS
K780720 · GAD
Berkeley Bio-Medical, Inc.
General & Plastic Surgery · 169d
Cleared Oct 17, 1978
IDENTI-CLAMPS
K780721 · GDJ
Berkeley Bio-Medical, Inc.
General & Plastic Surgery · 169d
Cleared Oct 17, 1978
DIALYZER, DISP., COIL, LUNDIA
K781102 · FHS
Gambro, Inc.
Gastroenterology & Urology · 106d
Cleared Oct 17, 1978
KIDNEY, ARTIFICIAL
K781153 · DJC
Bd Becton Dickinson Vacutainer...
Toxicology · 99d
Cleared Oct 17, 1978
TOWELS, SHEETS, PILLOWCASES
K781227 · KME
Abco Dealers, Inc.
General Hospital · 91d
Cleared Oct 17, 1978
OBJECTS PRECISION HANDLING TEST KIT
K781350 · ION
Metro. Hospital & Health Center
Physical Medicine · 71d
Cleared Oct 17, 1978
PILLOWS- SINGLE PATIENT USE
K781354 · KME
Abco Dealers, Inc.
General Hospital · 70d
Cleared Oct 17, 1978
PINT BOTTLE WELL
K781364 · KYX
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 71d