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
162169–162192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1981
SECTORTAC
K812606 · IYN
Echo Laboratories, Inc.
Radiology · 28d
Cleared Oct 13, 1981
POLYPHOS 500
K812616 · IZO
Siemens Corp.
Radiology · 28d
Cleared Oct 13, 1981
INFANT CARIDAC MONITOR
K812674 · DRT
Electromed Intl., Ltd.
Cardiovascular · 21d
Cleared Oct 13, 1981
DISPOSABLE SURGICAL FACE MASKS
K812675 · FXX
Irema USA , Ltd.
General Hospital · 21d
Cleared Oct 13, 1981
AMPLITONE-3
K812676 · LDE
Progressive Technology, Inc.
Cardiovascular · 21d
Cleared Oct 13, 1981
NEONATE FLEXFLOAT
K812683 · FOH
Pharmaquest Corp.
General Hospital · 21d
Cleared Oct 13, 1981
LIF-O-GEN #3000 OXYGEN CONCENTRATOR
K812693 · CAW
Lif-O-Gen, Inc.
Anesthesiology · 15d
Cleared Oct 13, 1981
DISK
K812695
American Heartline, Inc.
Cardiovascular · 21d
Cleared Oct 13, 1981
ORTHO-THERM INFRARED SENSOR
K812701 · IYM
Orthion Corp.
Radiology · 20d
Cleared Oct 13, 1981
TECA #TE 8
K812715 · IKN
Teca, Inc.
Neurology · 18d
Cleared Oct 13, 1981
PEARCE CORNEAL TREPHINE
K812723 · HRH
Visitec Co.
Ophthalmic · 15d
Cleared Oct 09, 1981
MDM ARTERIAL BLOOD GAS SYRINGE
K812560 · FMF
Martell Medical Products, Inc.
General Hospital · 31d
Cleared Oct 09, 1981
TOTAL CALCIUM REAGENT SET
K812835 · CIC
Anco Medical Reagents & Assoc.
Chemistry
Cleared Oct 09, 1981
LDH REAGENT SET
K812836 · CFH
Anco Medical Reagents & Assoc.
Chemistry
Cleared Oct 08, 1981
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
K812155 · GZB
Medtronic Vascular
Neurology · 71d
Cleared Oct 08, 1981
UTERINE ASPIRATION CURETTES(RIGID&FLEX)
K812426 · HHK
Medi-Spec
Obstetrics & Gynecology · 44d
Cleared Oct 08, 1981
TANARAMA
K812543 · FTC
Marketing Consultants of America
General & Plastic Surgery · 34d
Cleared Oct 08, 1981
SUNTANNING HOME UNIT
K812579 · FTC
Tannhut
General & Plastic Surgery · 28d
Cleared Oct 08, 1981
ISOLATED VOLTAGE/FREQUENCY CONVERTER
K812619 · HCC
Bio-Feedback Systems, Inc.
Neurology · 23d
Cleared Oct 08, 1981
ACA ANTITHROMBIN III TEST PACK
K812627 · JBQ
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 23d
Cleared Oct 08, 1981
ACA FIBRINOGEN TEST PACK
K812629 · KQJ
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 24d
Cleared Oct 08, 1981
DOTRICH ELECTRONIC AIR CLEANER #C500AM
K812656 · FRF
Leedal, Inc.
General Hospital · 20d
Cleared Oct 08, 1981
SELF-CENTERING HIP
K812672 · KWY
Depuy, Inc.
Orthopedic · 16d
Cleared Oct 08, 1981
ADULT FLEX FLOAT W/HEATER
K812681 · FOH
Pharmaquest Corp.
General Hospital · 16d