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
170257–170280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1978
COLLIMATOR, HEART CONTOUR
K781984 · KPW
Siemens Corp.
Radiology · 10d
Cleared Dec 04, 1978
URINARY DRAINAGE BAG
K781987 · KNY
Kelsar Corp.
Gastroenterology & Urology · 10d
Cleared Dec 04, 1978
CARDIAC INSULATION PAD
K781990 · DWF
Shiley, Inc.
Cardiovascular · 7d
Cleared Dec 01, 1978
PFT GASES
K781523 · BXY
Gardner Cryogenics
Anesthesiology · 87d
Cleared Dec 01, 1978
STIMULATOR, TN-3001 SOMATOSENSORY
K781704 · GWF
Tracor Instruments, Inc.
Neurology · 52d
Cleared Dec 01, 1978
MASK, BI FLO NASAL OXYGEN
K781741 · BYG
Inhal-O-Tech Medical Plastic
Anesthesiology · 55d
Cleared Dec 01, 1978
RESPONSE SYSTEM, TN-3000
K781743 · GWL
Tracor Instruments, Inc.
Neurology · 42d
Cleared Nov 30, 1978
MEDICAL PROTEIN HYDROLYSATE REVITAL
K780775 · KOZ
Robertson Resources, Inc.
General & Plastic Surgery · 210d
Cleared Nov 30, 1978
ECG ANALYZER, HIGH SPEED
K781911 · DSI
Cardio-Dynamics Laboratories, Inc.
Cardiovascular · 16d
Cleared Nov 29, 1978
CALIBRATOR, DYNAMIC
K781692 · DXM
Waters Assoc., Inc.
Cardiovascular · 56d
Cleared Nov 29, 1978
SLICK SET, CUFFED
K781808 · BTR
Polamedco, Inc.
Anesthesiology · 37d
Cleared Nov 29, 1978
BLOOD PRESSURE RECORDER
K781932 · DXN
Cardiodyne, Inc.
Cardiovascular · 9d
Cleared Nov 29, 1978
EKG ELECTRODES, DISPOSABLE
K781940 · DRX
Hayes Products, Inc.
Cardiovascular · 9d
Cleared Nov 29, 1978
CATHETER INTRODUCERS, ARTERISE
K781954 · DYB
C.R. Bard, Inc.
Cardiovascular · 8d
Cleared Nov 27, 1978
IMV SYSTEM
K780340 · CBD
Lkb Instruments, Inc.
General Hospital · 271d
Cleared Nov 27, 1978
L/U ARM-VASCULAR
K781571 · IYB
General Electric Co.
Radiology · 74d
Cleared Nov 27, 1978
PNEUMOGARD MODEL 1230
K781714 · CAP
Novametrix Medical Systems, Inc.
Anesthesiology · 52d
Cleared Nov 27, 1978
CAMERA, GCA-10A, LOW ENERGY
K781739 · IYX
Toshiba Medical Systems
Radiology · 41d
Cleared Nov 27, 1978
RESCAL
K781759 · BZA
Diemolding Corp.
Anesthesiology · 42d
Cleared Nov 27, 1978
CLINAC 2500
K781872 · IYE
Varian Assoc., Inc.
Radiology · 24d
Cleared Nov 27, 1978
BREATHING CIRCUIT PRODUCTS, ANESTHESIA
K781908 · CAI
Hospitak, Inc.
Anesthesiology · 13d
Cleared Nov 22, 1978
DELTA-FLOW
K780479 · KRA
Tri-Delta Intl.
Cardiovascular · 240d
Cleared Nov 22, 1978
PROCAINAMIDE CALIBRATOR KIT
K780732 · DLJ
Vitek Systems, Inc.
Toxicology · 204d
Cleared Nov 22, 1978
RUBELISA TEST KIT
K780996 · GON
Microbiological Assoc.
Microbiology · 162d