FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
170425–170448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 17, 1978
EMIT PROCAINAMIDE ASSAY
K781382 · LAR
Syva Co.
Toxicology · 67d
Cleared Oct 17, 1978
MIC-BIO-PLATE
K781506 · JSF
Pasco Laboratories, Inc.
Microbiology · 84d
Cleared Oct 17, 1978
ECG ELECTRODE, 2021, 2022, 2032, 2033
K781514 · DRX
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 46d
Cleared Oct 17, 1978
MAXIRAY 125 TUBE UNIT
K781524 · ITY
General Electric Co.
Radiology · 42d
Cleared Oct 17, 1978
SEPTAL BUTTON
K781529 · LFB
Xomed, Inc.
Ear, Nose, Throat · 42d
Cleared Oct 17, 1978
UMBILICAL CORD CLAMP
K781548 · HFW
Hollister, Inc.
Obstetrics & Gynecology · 35d